O'REGAN LIGATOR
FDA 510(k) clearance K963166 · decided 1997-05-05
Clearance details
- K-number
- K963166
- Device name
- O'REGAN LIGATOR
- Applicant
- Patrick J. O'Regan
- Decision
- Substantially Equivalent
- Date received
- 1996-08-14
- Decision date
- 1997-05-05
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- FHN
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Vancouver, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.