AMSEN DOUBLE-ENDED FORAMINAL PROBE

Orthopedic Manual Surgical Instrument

ADVANCED MED/SURG, INC.

The following data is part of a premarket notification filed by Advanced Med/surg, Inc. with the FDA for Amsen Double-ended Foraminal Probe.

Pre-market Notification Details

Device IDK921642
510k NumberK921642
Device Name:AMSEN DOUBLE-ENDED FORAMINAL PROBE
ClassificationOrthopedic Manual Surgical Instrument
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 CodeLXH  
CFR Regulation Number888.4540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-06
Decision Date1992-06-03

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