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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K001017
Device Name RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC
Applicant
RETRAX SAFETY SYSTEMS, INC.
1401 BRICKELL AVE SUITE 340
MIAMI,  FL  33131
Applicant Contact DAVID GARVIN
Correspondent
RETRAX SAFETY SYSTEMS, INC.
1401 BRICKELL AVE SUITE 340
MIAMI,  FL  33131
Correspondent Contact DAVID GARVIN
Regulation Number880.5860
Classification Product Code
MEG  
Date Received03/29/2000
Decision Date 06/02/2000
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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