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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 K881454
Device Name RETRACTABLE NEEDLE 3CC SYRINGE
Applicant
Kenmar Medical
1442 W. Collins, Unit F
Orange,  CA  92668
Applicant Contact KENNETH A WATTS
Correspondent
Kenmar Medical
1442 W. Collins, Unit F
Orange,  CA  92668
Correspondent Contact KENNETH A WATTS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/06/1988
Decision Date 12/08/1988
Decision Substantially Equivalent (SESE)
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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