POUCHES, PEEL OPEN, BREATHABLE

Wrap, Sterilization

SURGICOT, INC.

The following data is part of a premarket notification filed by Surgicot, Inc. with the FDA for Pouches, Peel Open, Breathable.

Pre-market Notification Details

Device IDK771032
510k NumberK771032
Device Name:POUCHES, PEEL OPEN, BREATHABLE
ClassificationWrap, Sterilization
Applicant SURGICOT, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-06-09
Decision Date1977-07-14

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