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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 K922248
Device Name MALLAWANY ATRAUMATIC TISSUE 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 Received05/13/1992
Decision Date 02/17/1994
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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