5010 VISUSTIM— 510(k) K822919
Substantially EquivalentLife-Tech Intl., Inc.
FDA 510(k) clearance K822919 for 5010 VISUSTIM, Substantially Equivalent on 1982-12-28. Applicant: Life-Tech Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Life-Tech Intl., Inc.
- Product code
- Code HLX
- Device class
- Class 2
- Regulation
- 21 CFR 886.1630
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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