The following data is part of a premarket notification filed by Closure Medical Corp. with the FDA for Octyldent (2-octyl Cyanoacrylate), 02a01.
| Device ID | K980159 |
| 510k Number | K980159 |
| Device Name: | OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 |
| Classification | Cement, Dental |
| Applicant | CLOSURE MEDICAL CORP. 5265 CAPITAL BLVD. Raleigh, NC 27616 |
| Contact | Joe B Barefoot |
| Correspondent | Joe B Barefoot CLOSURE MEDICAL CORP. 5265 CAPITAL BLVD. Raleigh, NC 27616 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-16 |
| Decision Date | 1998-04-09 |