510(k) K915388
- Device
- LAPAROCOPIC MYOMA SCREW
- Applicant
- COOK UROLOGICAL, INC.
- 510(k) number
- K915388
- Product code
- HHO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-05-18
- Date received
- 1991-11-29
- Regulation
- 884.4530
- Classification name
- Screw, Fibroid, Gynecological
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHELLE YOUNG
- Address
- 1100 W. Morgan St. P.O. Box 227 Spencer IN US 47460 47460
FDA Registration Numbers#
- 1820334
- 1825146
- 9612074
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HHO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K915412 | HYSTEROSCOPIC MYOMA SCREW | Cook Urological, Inc. | 1992-05-18 |
Legacy Summary#
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FDA Review#
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