E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES
FDA 510(k) clearance K921885 · decided 1994-03-25
Clearance details
- K-number
- K921885
- Device name
- E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES
- Applicant
- Valleylab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-21
- Decision date
- 1994-03-25
- Days to decision
- 703 days
- Clearance type
- Traditional
- Product code
- HGZ
- Device class
- 2
- Regulation number
- 884.5390
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.