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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K902157
Device Name JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR
Applicant
Johnson & Johnson Medical, Inc.
P.O. Box 90130
2500 Arbrook Blvd.
Arlington,  TX  76004
Applicant Contact RICHARD J SKALSKI
Correspondent
Johnson & Johnson Medical, Inc.
P.O. Box 90130
2500 Arbrook Blvd.
Arlington,  TX  76004
Correspondent Contact RICHARD J SKALSKI
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/15/1990
Decision Date 11/29/1990
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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