510(k) K980159
K980159 is an FDA 510(k) premarket notification submitted by Closure Medical Corp. for the device "OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01". The FDA issued a decision of Substantially Equivalent on April 9, 1998. The device falls under product code EMA (Cement, Dental), 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
- April 9, 1998
- Date Received
- January 16, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type