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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name I.V. Start Kit
510(k) Number K926031
Device Name PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT
Applicant
BRIGAM MEDICAL, INC.
393 EAST FLEMING DR.
POST OFFICE DRAWER 550
MORGANTON,  NC  28655
Applicant Contact KELLY L HEATH
Correspondent
BRIGAM MEDICAL, INC.
393 EAST FLEMING DR.
POST OFFICE DRAWER 550
MORGANTON,  NC  28655
Correspondent Contact KELLY L HEATH
Regulation Number880.5200
Classification Product Code
LRS  
Date Received12/01/1992
Decision Date 06/07/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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