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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 K960882
Device Name CONTROL SYRINGE
Applicant
Louisville Laboratories, Inc.
2400 Crittenden Dr.
Louisville,  KY  40217
Applicant Contact DAVID PHELPS
Correspondent
Louisville Laboratories, Inc.
2400 Crittenden Dr.
Louisville,  KY  40217
Correspondent Contact DAVID PHELPS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/20/1996
Decision Date 07/08/1996
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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