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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
510(k) Number K910154
Device Name USCI ILLUMEN-8 8F PTCA GUIDING CATHETER
Applicant
C.R. Bard, Inc.
1200 Technology Park Dr.
P.O. Box 7025
Billerica,  MA  01821
Applicant Contact JANET D BENSON
Correspondent
C.R. Bard, Inc.
1200 Technology Park Dr.
P.O. Box 7025
Billerica,  MA  01821
Correspondent Contact JANET D BENSON
Regulation Number862.3320
Classification Product Code
DOY  
Date Received01/14/1991
Decision Date 04/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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