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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heparin, Vascular Access Flush
510(k) Number K061497
Device Name SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
Applicant
Excelsior Medical Corp.
1933 Heck Ave.
Neptune,  NJ  07753
Applicant Contact JOHN TALARICO
Correspondent
Excelsior Medical Corp.
1933 Heck Ave.
Neptune,  NJ  07753
Correspondent Contact JOHN TALARICO
Regulation Number880.5200
Classification Product Code
NZW  
Date Received05/31/2006
Decision Date 02/23/2007
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
Recalls CDRH Recalls
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