LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS— 510(k) K870219
Substantially EquivalentLem Srl.
FDA 510(k) clearance K870219 for LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS, Substantially Equivalent on 1987-04-16. Applicant: Lem Srl.. Device class: 1.
Clearance details
- Applicant
- Lem Srl.
- Product code
- Code HQY
- Device class
- Class 1
- Regulation
- 21 CFR 886.5850
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Italy, IT
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