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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 K072654
Device Name PATIENT SAFE SYRINGE
Applicant
RETRACTABLE TECHNOLOGIES, INC.
511 LOBO LN.
LITTLE ELM,  TX  75068 -0009
Applicant Contact RHONDA WELLS
Correspondent
RETRACTABLE TECHNOLOGIES, INC.
511 LOBO LN.
LITTLE ELM,  TX  75068 -0009
Correspondent Contact RHONDA WELLS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/20/2007
Decision Date 12/14/2007
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
Predetermined Change
Control Plan Authorized		 No
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