Tympendi (810)— 510(k) K260266
Substantially EquivalentGrace Medical, Inc.
FDA 510(k) clearance K260266 for Tympendi (810), Substantially Equivalent on 2026-08-18. Applicant: Grace Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Grace Medical, Inc.
- Product code
- Code KHJ
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
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