MEDSPEC PACKING GAUZE

Gauze/sponge, Internal, X-ray Detectable

MEDSPEC CORP.

The following data is part of a premarket notification filed by Medspec Corp. with the FDA for Medspec Packing Gauze.

Pre-market Notification Details

Device IDK800281
510k NumberK800281
Device Name:MEDSPEC PACKING GAUZE
ClassificationGauze/sponge, Internal, X-ray Detectable
Applicant MEDSPEC CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGDY  
CFR Regulation Number878.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-02-05
Decision Date1980-03-12

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