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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 K780057
Device Name URINE SAMPLE COLLECTION KIT
Applicant
C.R. Bard, Inc.
110 Marshall Dr.
Warrendale,  PA  15086
Correspondent
C.R. Bard, Inc.
110 Marshall Dr.
Warrendale,  PA  15086
Regulation Number864.3250
Classification Product Code
FMH  
Date Received01/10/1978
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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