U.S.

Food & Orug:Admlnlstratlon·

10~0~.New Ha'ii1ps111t~Avenue
si1ve1 Spri11g, MD 20993 ·
[Link]

Q~RTlf:ICATE TO FO~~IGt:,J _G_QVERNMENT

- ·, .·',\,:~(d~r to·_§l~9W _the importation of United States products into foreign countries , _the u:s.-Food· and-D~ug _· -
: · A_dmir)lstratio11 ·(FDA) certifies the following information concerning the prodµct(s) to be exported Hsted b~low:
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: /:·,, ~ -J~lfme,·ou'ro~ubi~}:: -._ Name ofMaJlll~~,t~ter/Distrihiltor; Ad_c:lre~~.

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. · · ·t9 [Link]~diotion [Link] the Federal Food, Drug, and Cosmetic Act. ·· · ·. · . , . ·,,: · · ·

'\.>iir;:dertitietlJhat:t~~ aboV~; pr~duct{s) may be marketed in' and legally exported frorn; th~: unit~d States oi_;,: ~- -~-. -
.<:-~Arn~r:i_ca'.~ttni~dinis; The manufacturing. plarit(s} .in whic:h. the product(s) is produ:ced is suotecqo:perioaiq:. -·. · · _· -~- ' ·
· :_' - [n$p_ectitm's.·rtie last;suc.h lnspection showed that the plant(s). at that time, appeared to be in ·substantial · · ·, ·· _- _._.,
,.:7 cqm_pli~nife·wi~h ·.G..Un'_~nt·good ma_nufacturing practice requi ren:ients for the product(s) .listed abqve. _ . - . ·, , ,
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CDR Cesar A. Perez; PhD, Director- · ·_ · .. ·· '-
DRP.2: Division of Establishment Support.
, . Offlcei of-Regulatory Programs .... . . . ..
Office of Product Evaluation and Quality : ':
Center for Devices and Radtologi¢al Meiilth -·
- U.S:Food and Drug Admlnistration,DHHS

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U,S. Foo.d & Drllg Adm!~litraflon

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Slim Spring< MD2Q993
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-: -• Certificate No, .9644;6-2022

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·_ J DM1 NlSTRATIOM Sliver Spilng, Mt"20893
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·:. Certificate [Link] Government ~ Na.:ne of Product(s) Attachment Page 2 of 2
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