DISPOSABLE PLASTIC SYRINGES

Syringe, Piston

TRANSCOJECT GMBH & CO. KG

The following data is part of a premarket notification filed by Transcoject Gmbh & Co. Kg with the FDA for Disposable Plastic Syringes.

Pre-market Notification Details

Device IDK851523
510k NumberK851523
Device Name:DISPOSABLE PLASTIC SYRINGES
ClassificationSyringe, Piston
Applicant TRANSCOJECT GMBH & CO. KG RUGENSTRASSE 8 Neumuenster,  DE 24539
ContactO Kohler
CorrespondentO Kohler
TRANSCOJECT GMBH & CO. KG RUGENSTRASSE 8 Neumuenster,  DE 24539
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-16
Decision Date1985-07-24

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