IMAGYN INTRAUTERINE INSEMINATION DEVICE— 510(k) K945131
Substantially EquivalentImagyn Medical, Inc.
FDA 510(k) clearance K945131 for IMAGYN INTRAUTERINE INSEMINATION DEVICE, Substantially Equivalent on 1995-05-15. Applicant: Imagyn Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Imagyn Medical, 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
- Laguna Niguel, CA, US
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