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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Obstetrical
510(k) Number K013747
Device Name TEKNO-MEDICAL OBSTETRICAL FORCEPS
Applicant
Tekno Medical Optik-Chirurgie GmbH & Co.
Kaiserstr. 9
Tuningen, B.W.,  DE 78609
Applicant Contact MARKUS DENK
Correspondent
Tekno Medical Optik-Chirurgie GmbH & Co.
Kaiserstr. 9
Tuningen, B.W.,  DE 78609
Correspondent Contact MARKUS DENK
Regulation Number884.4400
Classification Product Code
HDA  
Date Received11/13/2001
Decision Date 02/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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