510(k) K964848
- Device
- WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM
- Applicant
- MARLOW SURGICAL TECHNOLOGIES, INC.
- 510(k) number
- K964848
- Product code
- MFD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-01-16
- Date received
- 1996-12-03
- Regulation
- 884.5250
- Classification name
- Cannula, Intrauterine Insemination
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- ARTHUR S GODDARD
- Address
- 1810 Joseph Lloyd Pkwy. Willoughby OH US 44094 44094
FDA Registration Numbers
- 3014755376
- 9610632
- 1825146
- 3014295858
- 9617744
- 1820334
- 3005987240
- 1319639
- 1216677
- 3010155661
- 2246552
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 30888937021333 | Wallace Artificial Insemination Catheter | Coopersurgical, Inc. | 2019-09-26 |
Legacy Summary
summary
FDA Review
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