TUBAL LUMEN SUPPORT
FDA 510(k) clearance K932114 · decided 1994-09-27
Clearance details
- K-number
- K932114
- Device name
- TUBAL LUMEN SUPPORT
- Applicant
- Cook Ob/Gyn
- Decision
- Substantially Equivalent
- Date received
- 1993-05-03
- Decision date
- 1994-09-27
- Days to decision
- 512 days
- Clearance type
- Traditional
- Product code
- HFJ
- Device class
- 2
- Regulation number
- 884.3650
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.