`THE INSEMINATOR' (PROPOSED)— 510(k) K984306
Substantially EquivalentWallach Surgical Devices, Inc.
FDA 510(k) clearance K984306 for `THE INSEMINATOR' (PROPOSED), Substantially Equivalent on 1999-03-01. Applicant: Wallach Surgical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Wallach Surgical Devices, Inc.
- Product code
- Code MFD
- Device class
- Class 2
- Regulation
- 21 CFR 884.5250
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orange, CT, US
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