CONFORM SHEETING, MODEL IGEL— 510(k) K012419
Substantially EquivalentImplantech Associates, Inc.
FDA 510(k) clearance K012419 for CONFORM SHEETING, MODEL IGEL, Substantially Equivalent on 2001-10-24. Applicant: Implantech Associates, Inc.. Device class: 1.
Clearance details
- Applicant
- Implantech Associates, Inc.
- Product code
- Code MDA
- Device class
- Class 1
- Regulation
- 21 CFR 878.4025
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ventura, CA, US
Recent devices under product code MDA
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