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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table And Attachments, Operating-Room
510(k) Number K925005
Device Name ISI SELF-SUPPORTING ARM
Applicant
Instrumentation Specialties, Inc.
32390 Ih-10 W.
Boerne,  TX  78006
Applicant Contact JOSEPH R KABANEK
Correspondent
Instrumentation Specialties, Inc.
32390 Ih-10 W.
Boerne,  TX  78006
Correspondent Contact JOSEPH R KABANEK
Regulation Number878.4950
Classification Product Code
BWN  
Date Received10/02/1992
Decision Date 04/29/1993
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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