GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES— 510(k) K062672
Substantially EquivalentGrace Medical, Inc.
FDA 510(k) clearance K062672 for GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES, Substantially Equivalent on 2006-10-24. Applicant: Grace Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Grace Medical, Inc.
- Product code
- Code ETD
- Device class
- Class 2
- Regulation
- 21 CFR 874.3880
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
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- K232702 — Solo+ Tympanostomy Tube Device (TTD)
- K233658 — Biowy Tym Tube (TT)
- K232059 — Tympanostomy Tubes
More clearances from Grace Medical, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.