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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discriminator, Two-Point
510(k) Number K874300
Device Name AESTHESIOMETER
Applicant
Orthopedic Systems, Inc.
1897 National Ave.
Hayward,  CA  94545
Applicant Contact ROBERTY R MOORE
Correspondent
Orthopedic Systems, Inc.
1897 National Ave.
Hayward,  CA  94545
Correspondent Contact ROBERTY R MOORE
Regulation Number882.1200
Classification Product Code
GWI  
Date Received10/20/1987
Decision Date 11/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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