STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE

Drape, Surgical

ANGIOSYSTEMS, INC.

The following data is part of a premarket notification filed by Angiosystems, Inc. with the FDA for Sterile Disposable Surgical Drape/abdominal Drape.

Pre-market Notification Details

Device IDK905466
510k NumberK905466
Device Name:STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE
ClassificationDrape, Surgical
Applicant ANGIOSYSTEMS, INC. C/O MEDICAL DEVICE INSPECITON 55 NORTHERN BLVD., SUITE 301 Great Neck,  NY  11021
ContactAlan P Schwartz
CorrespondentAlan P Schwartz
ANGIOSYSTEMS, INC. C/O MEDICAL DEVICE INSPECITON 55 NORTHERN BLVD., SUITE 301 Great Neck,  NY  11021
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-05
Decision Date1991-02-11

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