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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K923126
Device Name MALLAWANY TISSUE GRASPING FORCEPS
Applicant
NUMED TECHNOLOGIES, INC.
5755 GRANGER RD.
INDEPENDENCE,  OH  44131
Applicant Contact JAN J LEWANDOWSKI
Correspondent
NUMED TECHNOLOGIES, INC.
5755 GRANGER RD.
INDEPENDENCE,  OH  44131
Correspondent Contact JAN J LEWANDOWSKI
Regulation Number884.1720
Classification Product Code
HET  
Date Received06/26/1992
Decision Date 10/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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