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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Nephrostomy, General & Plastic Surgery
510(k) Number K820867
Device Name PERCUTANEOUS NEPHROSTOMY SET
Applicant
Van-Tec, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Van-Tec, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4200
Classification Product Code
GBO  
Date Received03/29/1982
Decision Date 04/13/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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