AESTHESIOMETER

Discriminator, Two-point

ORTHOPEDIC SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK874300
510k NumberK874300
Device Name:AESTHESIOMETER
ClassificationDiscriminator, Two-point
Applicant ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward,  CA  94545
ContactRoberty R Moore
CorrespondentRoberty R Moore
ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward,  CA  94545
Product CodeGWI  
CFR Regulation Number882.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-20
Decision Date1987-11-06

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