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FDA 510(k), K041176, URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
FDA 510(k), K041176, URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
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510(K) Number: K041176
Device Name: URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
Manufacturer: SOFRADIM PRODUCTION
Device Classification Name: mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Regulation Number: 878.3300
Classification Product Code: OTN
Date Received: 05/05/2004
Decision Date: 05/17/2004
Regulation Medical Specialty: General & Plastic Surgery
Device Name: URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
Manufacturer: SOFRADIM PRODUCTION
Device Classification Name: mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Regulation Number: 878.3300
Classification Product Code: OTN
Date Received: 05/05/2004
Decision Date: 05/17/2004
Regulation Medical Specialty: General & Plastic Surgery
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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