510(k) K991923
- Device
- SOOTHE-N-SEAL CANKER SORE RELIEF
- Applicant
- CLOSURE MEDICAL CORP.
- 510(k) number
- K991923
- Product code
- MZW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-09-02
- Date received
- 1999-06-07
- Regulation
- 872.3275
- Classification name
- Dental Cement W/out Zinc-oxide Eugenol As An Ulcer Covering For Pain Relief
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- W. THOMAS STEPHENS
- Address
- 5250 Greens Dairy Rd. Raleigh NC US 27616 27616
FDA Registration Numbers#
- 3006316962
- 3038718579
- 3012421607
- 3012187973
- 3032378317
- 3008912871
- 2024312
- 8020994
- 9680845
Source Documents#
Other 510(k) Records For Product Code MZW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073209 | MAXCEM 2 | Kerr Corporation | 2008-01-29 |
Legacy Summary#
summary
FDA Review#
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