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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name table, surgical with orthopedic accessories, manual
510(k) Number K881101
Device Name K ORTHOPEDIC TABLE
Applicant
INSTRUMENTATION SPECIALTIES, INC.
15700 CHASE HILL BLVD.
SAN ANTONIO,  TX  78256
Applicant Contact JOSEPH R KABANEK
Correspondent
INSTRUMENTATION SPECIALTIES, INC.
15700 CHASE HILL BLVD.
SAN ANTONIO,  TX  78256
Correspondent Contact JOSEPH R KABANEK
Regulation Number878.4950
Classification Product Code
JEB  
Date Received03/15/1988
Decision Date 04/06/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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