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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, polymeric
510(k) Number K031225
Device Name TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004
Original Applicant
GFE MEDIZINTECHNIK GMBH
6254 south 1280 east
salt lake city,  UT  84121
Original Contact john e sawyer
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
OXJ  
Date Received05/01/2003
Decision Date 09/29/2003
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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