ePTFE-Coated Auricular Implant— 510(k) K172389
Substantially EquivalentImplantech Associates, Inc.
FDA 510(k) clearance K172389 for ePTFE-Coated Auricular Implant, Substantially Equivalent on 2018-07-18. Applicant: Implantech Associates, Inc.. Device class: 2.
Clearance details
- Applicant
- Implantech Associates, Inc.
- Product code
- Code FZD
- Device class
- Class 2
- Regulation
- 21 CFR 878.3590
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ventura, CA, US
Recent devices under product code FZD
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- K071470 — IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
- K052504 — GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
Data sourced from openFDA. This site is unofficial and independent of the FDA.