FDA 510(k), K083839, AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
FDA 510(k), K083839, AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
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$149.00 USD
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510(K) Number: K083839
Device Name: AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
Manufacturer:
Device Classification Name: Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Regulation Number: 884.5980
Classification Product Code: OTP
Date Received: 12/23/2008
Decision Date: 01/15/2009
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
Manufacturer:
Device Classification Name: Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Regulation Number: 884.5980
Classification Product Code: OTP
Date Received: 12/23/2008
Decision Date: 01/15/2009
Regulation Medical Specialty: Obstetrics/Gynecology