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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K922405
Device Name O.R.C. ADAPTER
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 Number876.1500
Classification Product Code
GCJ  
Date Received05/21/1992
Decision Date 08/14/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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