LENS, POLYCORE— 510(k) K790215
Substantially EquivalentPolycore Optical Pte , Ltd.
FDA 510(k) clearance K790215 for LENS, POLYCORE, Substantially Equivalent on 1979-02-26. Applicant: Polycore Optical Pte , Ltd.. Device class: 1.
Clearance details
- Applicant
- Polycore Optical Pte , Ltd.
- Product code
- Code HQG
- Device class
- Class 1
- Regulation
- 21 CFR 886.5844
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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