The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Interface - Cavity Liner.
| Device ID | K897130 |
| 510k Number | K897130 |
| Device Name: | INTERFACE - CAVITY LINER |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
| Contact | Jan A Orlowski |
| Correspondent | Jan A Orlowski SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-27 |
| Decision Date | 1990-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850015110115 | K897130 | 000 |
| 00850015110443 | K897130 | 000 |
| 00850015110436 | K897130 | 000 |