MANIPUSEAL
FDA 510(k) clearance K051160 · decided 2005-09-02
Clearance details
- K-number
- K051160
- Device name
- MANIPUSEAL
- Applicant
- Insitu Systems
- Decision
- Substantially Equivalent
- Date received
- 2005-05-05
- Decision date
- 2005-09-02
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- HEW
- Device class
- 2
- Regulation number
- 884.1640
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.