PBN FALLOPIAN TUBE CATHETER SYSTEM
FDA 510(k) clearance K000620 · decided 2000-10-30
Clearance details
- K-number
- K000620
- Device name
- PBN FALLOPIAN TUBE CATHETER SYSTEM
- Applicant
- Medical Device Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-02-24
- Decision date
- 2000-10-30
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- MDG
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Gainesville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.