The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Curay Support.
| Device ID | K912788 |
| 510k Number | K912788 |
| Device Name: | CURAY SUPPORT |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 321 PRODUCER WAY Pomona, CA 91768 |
| Contact | Dr.jan A.orlowski |
| Correspondent | Dr.jan A.orlowski SCIENTIFIC PHARMACEUTICALS, INC. 321 PRODUCER WAY Pomona, CA 91768 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-24 |
| Decision Date | 1991-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D801SP55321 | K912788 | 000 |
| D801ID55303I1 | K912788 | 000 |
| D801ID55304I1 | K912788 | 000 |
| D801SP55291 | K912788 | 000 |
| D801SP55301 | K912788 | 000 |
| D801SP55301B1 | K912788 | 000 |
| D801SP55301N1 | K912788 | 000 |
| D801SP55302B1 | K912788 | 000 |
| D801SP55302N1 | K912788 | 000 |
| D801SP55303B1 | K912788 | 000 |
| D801SP55303N1 | K912788 | 000 |
| D801SP55304B1 | K912788 | 000 |
| D801SP55304N1 | K912788 | 000 |
| D801SP55305B1 | K912788 | 000 |
| D801SP55305N1 | K912788 | 000 |
| D801SP5530C1 | K912788 | 000 |
| D801SP55311 | K912788 | 000 |
| D801ID55302I1 | K912788 | 000 |