QUANTUM 412— 510(k) K844570
Substantially EquivalentKeta Corp.
FDA 510(k) clearance K844570 for QUANTUM 412, Substantially Equivalent on 1984-12-05. Applicant: Keta Corp.. Device class: 1.
Clearance details
- Applicant
- Keta Corp.
- Product code
- Code HPT
- Device class
- Class 1
- Regulation
- 21 CFR 886.1605
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danvers, MA, US
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