LULMITEX NEONATAL TRANSILLUMINATOR— 510(k) K912747
Substantially EquivalentLumitex, Inc.
FDA 510(k) clearance K912747 for LULMITEX NEONATAL TRANSILLUMINATOR, Substantially Equivalent on 1991-12-24. Applicant: Lumitex, Inc.. Device class: 1.
Clearance details
- Applicant
- Lumitex, Inc.
- Product code
- Code HJN
- Device class
- Class 1
- Regulation
- 21 CFR 886.1945
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cleveland, OH, US
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