SURGICAL EYE SHIELD— 510(k) K781960
Substantially EquivalentConcept, Inc.
FDA 510(k) clearance K781960 for SURGICAL EYE SHIELD, Substantially Equivalent on 1979-02-09. Applicant: Concept, Inc.. Device class: 2.
Clearance details
- Applicant
- Concept, Inc.
- Product code
- Code HJK
- Device class
- Class 2
- Regulation
- 21 CFR 886.1385
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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