ENDOSCOPIC ELASTIC BAND LIGATOR
FDA 510(k) clearance K880648 · decided 1988-04-06
Clearance details
- K-number
- K880648
- Device name
- ENDOSCOPIC ELASTIC BAND LIGATOR
- Applicant
- Superior Healthcare Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-02-17
- Decision date
- 1988-04-06
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- FHN
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Cumberland, RI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.