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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, tubing, blood, with and without anti-regurgitation valve
510(k) Number K892932
Device Name BIOPRIME TM KIT
Applicant
HOSPAL
460 MCLAWS CIRCLE
SUITE 200
WILLIAMSBURG,  VA  23185
Applicant Contact JO LANG
Correspondent
HOSPAL
460 MCLAWS CIRCLE
SUITE 200
WILLIAMSBURG,  VA  23185
Correspondent Contact JO LANG
Regulation Number876.5820
Classification Product Code
FJK  
Date Received04/21/1989
Decision Date 06/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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