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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 K946219
Device Name POP-N-LOK SYRINGE
Applicant
Retractable Technologies, Inc.
622 S. Mill St.
Lewisville,  TX  75057
Applicant Contact TOD S HEWITT
Correspondent
Retractable Technologies, Inc.
622 S. Mill St.
Lewisville,  TX  75057
Correspondent Contact TOD S HEWITT
Regulation Number880.5860
Classification Product Code
MEG  
Date Received12/21/1994
Decision Date 12/28/1995
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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