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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 K881791
Device Name STERA DISPOSABLE SYRINGES
Applicant
Excel U.S.A.
1520 W. Cameron Ave., Suite
270
West Covina,  CA  91790
Applicant Contact DAVID T BOEN
Correspondent
Excel U.S.A.
1520 W. Cameron Ave., Suite
270
West Covina,  CA  91790
Correspondent Contact DAVID T BOEN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/26/1988
Decision Date 12/22/1988
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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