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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K953655
Device Name J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS
Applicant
Johnson & Johnson Medical, Inc.
2500 Arbrook Blvd.
P.O.Box 90130
Arlington,  TX  76004 -0130
Applicant Contact WILLIAM P ROBB
Correspondent
Johnson & Johnson Medical, Inc.
2500 Arbrook Blvd.
P.O.Box 90130
Arlington,  TX  76004 -0130
Correspondent Contact WILLIAM P ROBB
Regulation Number876.1500
Classification Product Code
OCX  
Date Received08/04/1995
Decision Date 10/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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