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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator, Culdoscopic (And Accessories)
510(k) Number K930571
Device Name REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING
Applicant
Numed Technologies, Inc.
5755 Granger Rd.
Independence,  OH  44131
Applicant Contact JAN LEWANDOWSKI
Correspondent
Numed Technologies, Inc.
5755 Granger Rd.
Independence,  OH  44131
Correspondent Contact JAN LEWANDOWSKI
Regulation Number884.4160
Classification Product Code
HFI  
Date Received02/04/1993
Decision Date 02/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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