Bio Guard Air/Water & Suction Valves— 510(k) K192059
Substantially EquivalentUnited States Endoscopy Group, Inc.
FDA 510(k) clearance K192059 for Bio Guard Air/Water & Suction Valves, Substantially Equivalent on 2019-09-17. Applicant: United States Endoscopy Group, Inc.. Device class: 2.
Clearance details
- Applicant
- United States Endoscopy Group, 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
- Special
- Location
- Mentor, OH, US
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