DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304— 510(k) K102409
Substantially EquivalentByrne Medical, Inc.
FDA 510(k) clearance K102409 for DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304, Substantially Equivalent on 2010-11-04. Applicant: Byrne Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Byrne Medical, Inc.
- Product code
- Code ODC
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Conroe, TX, US
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