510(k) K131396
- Device
- WIRED MOUTH PROTECTOR (WMP)
- Applicant
- ELBA LABORATORIES, INC.
- 510(k) number
- K131396
- Product code
- PFL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-09-30
- Date received
- 2013-05-15
- Regulation
- 872.6890
- Classification name
- Intraoral, Dental Foam Protector
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD A HAMER
- Address
- 780 W. 8 Mile Rd. Ferndale MI US 48220 48220
FDA Registration Numbers#
- 3043303267
- 8040278
- 3014707731
- 3015422158
- 1420089
Source Documents#
Legacy Summary#
summary
FDA Review#
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