AMSET PLD SYSTEM

Arthroscope

ADVANCED MED/SURG, INC.

The following data is part of a premarket notification filed by Advanced Med/surg, Inc. with the FDA for Amset Pld System.

Pre-market Notification Details

Device IDK905014
510k NumberK905014
Device Name:AMSET PLD SYSTEM
ClassificationArthroscope
Applicant ADVANCED MED/SURG, INC. 25590 SEABOARD LN. Hayward,  CA  94545
ContactRonald C Allen
CorrespondentRonald C Allen
ADVANCED MED/SURG, INC. 25590 SEABOARD LN. Hayward,  CA  94545
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-06
Decision Date1991-04-01

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