OCUTOME MODEL 8000— 510(k) K791898
Substantially EquivalentCooper Medical Devices Corp.
FDA 510(k) clearance K791898 for OCUTOME MODEL 8000, Substantially Equivalent on 1979-10-30. Applicant: Cooper Medical Devices Corp.. Device class: 2.
Clearance details
- Applicant
- Cooper Medical Devices Corp.
- Product code
- Code HKP
- Device class
- Class 2
- Regulation
- 21 CFR 886.4150
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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