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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resectoscope, Working Element
510(k) Number K991426
Device Name MAHE INSTRUMENTS
Applicant
MAHE INTL., INC.
300 JAMES ROBERTSON PKWY.
NASHVILLE,  TN  37201
Applicant Contact WINIFRIED REICH
Correspondent
MAHE INTL., INC.
300 JAMES ROBERTSON PKWY.
NASHVILLE,  TN  37201
Correspondent Contact WINIFRIED REICH
Regulation Number876.1500
Classification Product Code
FDC  
Subsequent Product Codes
FAS   FJL  
Date Received04/23/1999
Decision Date 08/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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