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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Single Patient Use, Portable, Nonpowered
510(k) Number K922895
Device Name J-VAC BULB SUCTION RESERVOIR
Applicant
Johnson & Johnson Medical, Inc.
P.O. Box 90130
Arlington,  TX  76004
Applicant Contact T. M WENDT
Correspondent
Johnson & Johnson Medical, Inc.
P.O. Box 90130
Arlington,  TX  76004
Correspondent Contact T. M WENDT
Regulation Number878.4680
Classification Product Code
GCY  
Date Received06/16/1992
Decision Date 09/15/1992
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
Predetermined Change
Control Plan Authorized		 No
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