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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
510(k) Number K830226
Device Name SURGITEK PERCUTANEOUS NEPHROSTOMY CATH
Applicant
Medical Engineering Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medical Engineering Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
LJE  
Date Received01/24/1983
Decision Date 02/09/1983
Decision Substantially Equivalent (SESE)
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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