The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Apco Fissure Sealer & Bonding Agent.
| Device ID | K843098 |
| 510k Number | K843098 |
| Device Name: | APCO FISSURE SEALER & BONDING AGENT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-07 |
| Decision Date | 1984-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816526020589 | K843098 | 000 |
| 00816526020398 | K843098 | 000 |
| 00816526020329 | K843098 | 000 |
| 00816526020312 | K843098 | 000 |
| 00816526020282 | K843098 | 000 |
| 00816526020275 | K843098 | 000 |