GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System— 510(k) K181151
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K181151 for GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System, Substantially Equivalent on 2018-08-10. Applicant: ETHICON, Inc.. Device class: 2.
Clearance details
- Applicant
- ETHICON, Inc.
- Product code
- Code PWJ
- Device class
- Class 2
- Regulation
- 21 CFR 884.4910
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.