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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K962938
Device Name EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)
Applicant
Excelsior Medical Corp.
P.O. Box 299
Long Branch,  NJ  07740
Applicant Contact DAVID LUMIA
Correspondent
Excelsior Medical Corp.
P.O. Box 299
Long Branch,  NJ  07740
Correspondent Contact DAVID LUMIA
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/29/1996
Decision Date 10/25/1996
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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