HAEMOBAND MULTI-LIGATOR
FDA 510(k) clearance K091519 · decided 2009-07-28
Clearance details
- K-number
- K091519
- Device name
- HAEMOBAND MULTI-LIGATOR
- Applicant
- Haemoband Surgical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-22
- Decision date
- 2009-07-28
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- FHN
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.