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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
Applicant
Gfe Medizintechnik GmbH
6254 S. 1280 E.
Salt Lake City,  UT  84121
Applicant Contact JOHN E SAWYER
Correspondent
Gfe Medizintechnik GmbH
6254 S. 1280 E.
Salt Lake City,  UT  84121
Correspondent Contact JOHN E SAWYER
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
OXJ  
Date Received04/17/2003
Decision Date 09/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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