PLASTER STAND

Instrument, Cast Application/removal, Manual

ORTHOPEDIC SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK870100
510k NumberK870100
Device Name:PLASTER STAND
ClassificationInstrument, Cast Application/removal, Manual
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 CodeLGG  
CFR Regulation Number888.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-09
Decision Date1987-01-28

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