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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Suprapubic (And Accessories)
510(k) Number K810368
Device Name VANCE PERCUTANEOUS MALECOT NEPHROSTOMY
Applicant
Vance Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Vance Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5090
Classification Product Code
KOB  
Date Received02/12/1981
Decision Date 03/20/1981
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
Recalls CDRH Recalls
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