510(k) Premarket Notification

• 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 south 1280 east; salt lake city, UT 84121
• Contact: john e sawyer
• Regulation Number: 878.3300
• Classification Product Code: FTL
• Subsequent Product Code: OXJ
• Date Received: 05/01/2003
• 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