FDA 510(k), K063712, AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
FDA 510(k), K063712, AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
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$149.00 USD
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510(K) Number: K063712
Device Name: AVAULTA 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: 12/14/2006
Decision Date: 03/12/2007
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: AVAULTA 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: 12/14/2006
Decision Date: 03/12/2007
Regulation Medical Specialty: Obstetrics/Gynecology