ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector— 510(k) K191438
Substantially EquivalentErbe USA, Inc.
FDA 510(k) clearance K191438 for ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector, Substantially Equivalent on 2019-06-27. Applicant: Erbe USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Erbe USA, 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
- Special
- Location
- Marietta, GA, US
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