SURGIFLATOR-20 ECU
FDA 510(k) clearance K981859 · decided 1998-06-26
Clearance details
- K-number
- K981859
- Device name
- SURGIFLATOR-20 ECU
- Applicant
- W.O.M. World of Medicine GmbH
- Decision
- Substantially Equivalent
- Date received
- 1998-05-27
- Decision date
- 1998-06-26
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.