The following data is part of a premarket notification filed by Closure Medical Corp. with the FDA for Soothe-n-seal Canker Sore Relief.
| Device ID | K991923 |
| 510k Number | K991923 |
| Device Name: | SOOTHE-N-SEAL CANKER SORE RELIEF |
| Classification | Dental Cement W/out Zinc-oxide Eugenol As An Ulcer Covering For Pain Relief |
| Applicant | CLOSURE MEDICAL CORP. 5250 GREENS DAIRY RD. Raleigh, NC 27616 |
| Contact | W. Thomas Stephens |
| Correspondent | W. Thomas Stephens CLOSURE MEDICAL CORP. 5250 GREENS DAIRY RD. Raleigh, NC 27616 |
| Product Code | MZW |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-07 |
| Decision Date | 1999-09-02 |
| Summary: | summary |