OBSTETRICAL VACUUM CUP
FDA 510(k) clearance K911326 · decided 1991-08-14
Clearance details
- K-number
- K911326
- Device name
- OBSTETRICAL VACUUM CUP
- Applicant
- Gesco Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-26
- Decision date
- 1991-08-14
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- HDB
- Device class
- 2
- Regulation number
- 884.4340
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.