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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 K092827
Device Name DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX
Applicant
Dimeda Instrumente GmbH
Schwarzwaldstrabe 5
Tuttlingen,  DE 78532
Applicant Contact ANDREA PECSI
Correspondent
Dimeda Instrumente GmbH
Schwarzwaldstrabe 5
Tuttlingen,  DE 78532
Correspondent Contact ANDREA PECSI
Regulation Number884.4400
Classification Product Code
HDA  
Date Received09/14/2009
Decision Date 01/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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