SURGICAL DRAPE

Drape, Surgical

AMERICAN MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by American Medical Technology, Inc. with the FDA for Surgical Drape.

Pre-market Notification Details

Device IDK873313
510k NumberK873313
Device Name:SURGICAL DRAPE
ClassificationDrape, Surgical
Applicant AMERICAN MEDICAL TECHNOLOGY, INC. C/O VENTURE MGMT CONSULTING BOX 160 GRAND VIEW TERRACE EXT Brooklyn,  CT  06234
ContactZamba, P.e.
CorrespondentZamba, P.e.
AMERICAN MEDICAL TECHNOLOGY, INC. C/O VENTURE MGMT CONSULTING BOX 160 GRAND VIEW TERRACE EXT Brooklyn,  CT  06234
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-17
Decision Date1987-09-04

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