MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.— 510(k) K871030
Substantially EquivalentDirected Energy, Inc.
FDA 510(k) clearance K871030 for MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO., Substantially Equivalent on 1987-05-15. Applicant: Directed Energy, Inc.. Device class: 2.
Clearance details
- Applicant
- Directed Energy, Inc.
- Product code
- Code LNK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
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