HYSTEREOSCOPY PUMP HM4
FDA 510(k) clearance K022449 · decided 2003-04-10
Clearance details
- K-number
- K022449
- Device name
- HYSTEREOSCOPY PUMP HM4
- Applicant
- W.O.M. World of Medicine AG
- Decision
- Substantially Equivalent
- Date received
- 2002-07-26
- Decision date
- 2003-04-10
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- HIG
- Device class
- 2
- Regulation number
- 884.1700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.