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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 K083193
Device Name REVAC AUTO RETRACTABLE SAFETY SYRINGE
Applicant
REVOLUTIONS MEDICAL CORPORATION INC
670 Marina Drive
3rd Floor
Charleston,  SC  29492
Applicant Contact RICHARD THERIAULT
Correspondent
REVOLUTIONS MEDICAL CORPORATION INC
670 Marina Drive
3rd Floor
Charleston,  SC  29492
Correspondent Contact RICHARD THERIAULT
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
MEG  
Date Received10/29/2008
Decision Date 02/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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