510(k) K932114
- Device
- TUBAL LUMEN SUPPORT
- Applicant
- COOK OB/GYN
- 510(k) number
- K932114
- Product code
- HFJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-09-27
- Date received
- 1993-05-03
- Regulation
- 884.3650
- Classification name
- Prosthesis, Fallopian Tube
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TAMMY BACON
- Address
- 1100 W. Morgan St. P.O. Box 271 Spencer IN US 47460 47460
Source Documents#
Legacy Summary#
summary
FDA Review#
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