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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K930399
Device Name ORC ENDOSCOPIC INSTRUMENT HOLDER
Applicant
O.R. Concepts, Inc.
200 N. Oak St.
Roanoke,  TX  76262
Applicant Contact JOHN MAYALL
Correspondent
O.R. Concepts, Inc.
200 N. Oak St.
Roanoke,  TX  76262
Correspondent Contact JOHN MAYALL
Regulation Number878.4800
Classification Product Code
MDM  
Date Received01/26/1993
Decision Date 02/17/1993
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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