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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Peritoneal
510(k) Number K770602
Device Name VALVE, ASCITES, LAVEEN
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5955
Classification Product Code
KPM  
Date Received03/30/1977
Decision Date 04/15/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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