Ax-Surgi Surgical Hemostat— 510(k) K213198
Substantially EquivalentAdvamedica, Inc.
FDA 510(k) clearance K213198 for Ax-Surgi Surgical Hemostat, Substantially Equivalent on 2023-01-05. Applicant: Advamedica, Inc.. Device class: 2.
Clearance details
- Applicant
- Advamedica, Inc.
- Product code
- Code POD
- Device class
- Class 2
- Regulation
- 21 CFR 878.4454
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
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