SNORKEL
FDA 510(k) clearance K112766 · decided 2012-06-04
Clearance details
- K-number
- K112766
- Device name
- SNORKEL
- Applicant
- Fellmar Company
- Decision
- Substantially Equivalent
- Date received
- 2011-09-22
- Decision date
- 2012-06-04
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- LQZ
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Monrovia, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.