WIRED MOUTH PROTECTOR (WMP)
FDA 510(k) clearance K131396 · decided 2013-09-30
Clearance details
- K-number
- K131396
- Device name
- WIRED MOUTH PROTECTOR (WMP)
- Applicant
- Elba Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-05-15
- Decision date
- 2013-09-30
- Days to decision
- 138 days
- Clearance type
- Traditional
- Product code
- PFL
- Device class
- 1
- Regulation number
- 872.6890
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Ferndale, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.