LACERATION AND INSTRUMENT TRAYS

Tray, Surgical

ADVANTAGE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Laceration And Instrument Trays.

Pre-market Notification Details

Device IDK873290
510k NumberK873290
Device Name:LACERATION AND INSTRUMENT TRAYS
ClassificationTray, Surgical
Applicant ADVANTAGE MEDICAL SYSTEMS, INC. 905 SHEEHY DR. Horsham,  PA  19044
ContactJoel A Marcus
CorrespondentJoel A Marcus
ADVANTAGE MEDICAL SYSTEMS, INC. 905 SHEEHY DR. Horsham,  PA  19044
Product CodeLRP  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-17
Decision Date1987-09-24

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