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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
Predetermined Change
Control Plan Authorized		 No
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