SURGIFLATOR
FDA 510(k) clearance K921264 · decided 1992-10-09
Clearance details
- K-number
- K921264
- Device name
- SURGIFLATOR
- Applicant
- W.O.M. World of Medicine GmbH
- Decision
- Substantially Equivalent
- Date received
- 1992-03-16
- Decision date
- 1992-10-09
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Tucson, AR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.