DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)— 510(k) K090851
Substantially EquivalentByrne Medical, Inc.
FDA 510(k) clearance K090851 for DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R), Substantially Equivalent on 2009-07-02. 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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