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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 K881980
Device Name RETROJECT(TM) ANTI-AIDS SYRINGE W/RETRAC. NEEDLE
Applicant
Habley Medical Technology Corp.
22982 Alcalde Dr.
Laguana Hills,  CA  92653
Applicant Contact MCGOVERN HABER
Correspondent
Habley Medical Technology Corp.
22982 Alcalde Dr.
Laguana Hills,  CA  92653
Correspondent Contact MCGOVERN HABER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/12/1988
Decision Date 06/28/1988
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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