SURGICAL DRAPE

Drape, Surgical

AMSCO STERILE RECOVERIES, INC.

The following data is part of a premarket notification filed by Amsco Sterile Recoveries, Inc. with the FDA for Surgical Drape.

Pre-market Notification Details

Device IDK921049
510k NumberK921049
Device Name:SURGICAL DRAPE
ClassificationDrape, Surgical
Applicant AMSCO STERILE RECOVERIES, INC. 28100 U.S. HWY, 19N., STE. 201 Clearwater,  FL  34621
ContactDenise A Schottler
CorrespondentDenise A Schottler
AMSCO STERILE RECOVERIES, INC. 28100 U.S. HWY, 19N., STE. 201 Clearwater,  FL  34621
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-05
Decision Date1992-10-01

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