Boa Endoscopic Valve— 510(k) K152140
Substantially EquivalentC2 Therapeutics, Inc.
FDA 510(k) clearance K152140 for Boa Endoscopic Valve, Substantially Equivalent on 2015-10-13. Applicant: C2 Therapeutics, Inc.. Device class: 2.
Clearance details
- Applicant
- C2 Therapeutics, Inc.
- Product code
- Code OCX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood, Ca, CA, US
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