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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 K964230
Device Name CORELIFE
Applicant
Core Healthcare , Ltd.
46 Lock Haven Ln.
Battle Creek,  MI  49015
Applicant Contact KUMAR KULKARNI
Correspondent
Core Healthcare , Ltd.
46 Lock Haven Ln.
Battle Creek,  MI  49015
Correspondent Contact KUMAR KULKARNI
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/23/1996
Decision Date 07/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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