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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cholangiography
510(k) Number K920643
Device Name LAPAROSCOPIC 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 Number878.4200
Classification Product Code
GBZ  
Date Received02/12/1992
Decision Date 05/06/1992
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
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