SUNSHOWER MODEL HU-01-12L— 510(k) K850493
Substantially EquivalentSunthetic Engineering, Inc.
FDA 510(k) clearance K850493 for SUNSHOWER MODEL HU-01-12L, Substantially Equivalent on 1985-02-28. Applicant: Sunthetic Engineering, Inc.. Device class: 2.
Clearance details
- Applicant
- Sunthetic Engineering, Inc.
- Product code
- Code FTC
- Device class
- Class 2
- Regulation
- 21 CFR 878.4630
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marion, IA, US
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