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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K913804
Device Name EXCELSIOR SINGLE LEAD DISPENSING SET
Applicant
Excel Medical, Inc.
P.O. Box 1353
Asbury Park,  NJ  07712
Applicant Contact MARGARET LUMIA
Correspondent
Excel Medical, Inc.
P.O. Box 1353
Asbury Park,  NJ  07712
Correspondent Contact MARGARET LUMIA
Regulation Number880.5440
Classification Product Code
LHI  
Date Received08/26/1991
Decision Date 02/11/1992
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
Recalls CDRH Recalls
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