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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 K936040
Device Name HYPO(R) SAFETY CARTRIDGE SYRINGE
Applicant
Smith & Nephew, Inc.
Mpl
9400 King St.
Franklin Park,  IL  60131
Applicant Contact GLENN B MILLER
Correspondent
Smith & Nephew, Inc.
Mpl
9400 King St.
Franklin Park,  IL  60131
Correspondent Contact GLENN B MILLER
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Code
DZM  
Date Received12/20/1993
Decision Date 05/01/1995
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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