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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Specimen, Sterile
510(k) Number K780167
Device Name CATH KIT, URINE SPECIMEN
Applicant
C.R. Bard, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
C.R. Bard, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.3250
Classification Product Code
FMH  
Date Received02/02/1978
Decision Date 02/21/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
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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