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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 K854877
Device Name ACU-SYRINGE W/WO NEEDLES
Applicant
Acuderm, Inc.
3750 Hacienda Blvd.
Ft Lauderdale,  FL  33314
Applicant Contact CHARLES YEH
Correspondent
Acuderm, Inc.
3750 Hacienda Blvd.
Ft Lauderdale,  FL  33314
Correspondent Contact CHARLES YEH
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/06/1985
Decision Date 02/19/1986
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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