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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K942349
Device Name MICROBORE EXTENSION SET
Applicant
Excelsior Medical Corp.
P.O. Box 297
Long Branch,  NJ  07740
Applicant Contact DAVID LUMIA
Correspondent
Excelsior Medical Corp.
P.O. Box 297
Long Branch,  NJ  07740
Correspondent Contact DAVID LUMIA
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/17/1994
Decision Date 02/08/1995
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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