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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 K073206
Device Name NEEDLE-TRAP/NEEDLE SAFETY LABEL
Applicant
Schreiner Medipharm
7609 Cameron Circle
Fort Myers,  FL  33912
Applicant Contact Lee Leichter
Correspondent
Schreiner Medipharm
7609 Cameron Circle
Fort Myers,  FL  33912
Correspondent Contact Lee Leichter
Regulation Number880.5860
Classification Product Code
MEG  
Date Received11/13/2007
Decision Date 01/16/2008
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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