KDF-2.3— 510(k) K894264
Substantially EquivalentUnimar, Inc.
FDA 510(k) clearance K894264 for KDF-2.3, Substantially Equivalent on 1989-08-15. Applicant: Unimar, Inc.. Device class: 2.
Clearance details
- Applicant
- Unimar, Inc.
- Product code
- Code HDR
- Device class
- Class 2
- Regulation
- 21 CFR 884.5250
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilton, CT, US
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