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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 K883227
Device Name SKIFA, PLASTIC DISPOSABLE SYRINGE
Applicant
P.T. Setio Harto , Ltd.
Frank Strausser
35455 Via Sol Vista
Rancho,  CA  92390
Applicant Contact STRAUSSER, INC.
Correspondent
P.T. Setio Harto , Ltd.
Frank Strausser
35455 Via Sol Vista
Rancho,  CA  92390
Correspondent Contact STRAUSSER, INC.
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/01/1988
Decision Date 09/29/1988
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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