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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 K914782
Device Name SUCTION/IRRIGATION PROBE
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 Received10/23/1991
Decision Date 12/09/1991
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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