SEA-BOND
FDA 510(k) clearance K863375 · decided 1986-09-19
Clearance details
- K-number
- K863375
- Device name
- SEA-BOND
- Applicant
- Combe, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-03
- Decision date
- 1986-09-19
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- KXX
- Device class
- 1
- Regulation number
- 872.3450
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- White Plains, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.