GOLFF Sterile Anti-Fog Solution— 510(k) K231822
Substantially EquivalentBatrik Medical Manufacturing, Inc.
FDA 510(k) clearance K231822 for GOLFF Sterile Anti-Fog Solution, Substantially Equivalent on 2024-02-26. Applicant: Batrik Medical Manufacturing, Inc.. Device class: 2.
Clearance details
- Applicant
- Batrik Medical Manufacturing, Inc.
- Product code
- Code OCT
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lachine, CA
Recent devices under product code OCT
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