510(k) K991923
K991923 is an FDA 510(k) premarket notification submitted by Closure Medical Corp. for the device "SOOTHE-N-SEAL CANKER SORE RELIEF". The FDA issued a decision of Substantially Equivalent on September 2, 1999. The device falls under product code MZW (Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief), a Class II device regulated under 21 CFR 872.3275. Closure Medical Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 1999
- Date Received
- June 7, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type