Bodygard SFS Surgical Gown Level 4

Gown, Surgical

Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri

The following data is part of a premarket notification filed by Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri with the FDA for Bodygard Sfs Surgical Gown Level 4.

Pre-market Notification Details

Device IDK221139
510k NumberK221139
Device Name:Bodygard SFS Surgical Gown Level 4
ClassificationGown, Surgical
Applicant Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi Ve Tic A. S. Eskisehir Organize Sanayi Bolgesi 26, Cadde No. 9 Odunpazari,  TR 26110
ContactAli Serdar Serteser
CorrespondentDarren Reeves
DP Distribution & Consulting, LLC 12240 Hunting Horn Lane Rockville,  VA  23146
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-19
Decision Date2022-11-10

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