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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 K902401
Device Name CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM
Applicant
BURRON MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM,  PA  18018
Applicant Contact PEGGY KEIFFER
Correspondent
BURRON MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM,  PA  18018
Correspondent Contact PEGGY KEIFFER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/30/1990
Decision Date 10/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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