HERMAN CANNULA SET

Arthroscope

ORTHOPEDIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Herman Cannula Set.

Pre-market Notification Details

Device IDK880203
510k NumberK880203
Device Name:HERMAN CANNULA SET
ClassificationArthroscope
Applicant ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward,  CA  94545
ContactRobert R Moore
CorrespondentRobert R Moore
ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward,  CA  94545
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-15
Decision Date1988-04-14

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