The following data is part of a premarket notification filed by Coe Laboratories, Inc. with the FDA for Perma-cryl 20.
| Device ID | K792427 |
| 510k Number | K792427 |
| Device Name: | PERMA-CRYL 20 |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | COE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-27 |
| Decision Date | 1979-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6583497031 | K792427 | 000 |
| 10386040007535 | K792427 | 000 |
| 10386040007528 | K792427 | 000 |
| 10386040007511 | K792427 | 000 |
| 10386040007504 | K792427 | 000 |
| 10386040007498 | K792427 | 000 |
| 10386040007481 | K792427 | 000 |
| 10386040007474 | K792427 | 000 |
| 10386040007467 | K792427 | 000 |
| 10386040007450 | K792427 | 000 |
| 10386040007443 | K792427 | 000 |
| 10386040007542 | K792427 | 000 |
| 10386040007559 | K792427 | 000 |
| 10386040007658 | K792427 | 000 |
| 10386040007641 | K792427 | 000 |
| 10386040007634 | K792427 | 000 |
| 10386040007627 | K792427 | 000 |
| 10386040007610 | K792427 | 000 |
| 10386040007603 | K792427 | 000 |
| 10386040007597 | K792427 | 000 |
| 10386040007580 | K792427 | 000 |
| 10386040007573 | K792427 | 000 |
| 10386040007566 | K792427 | 000 |
| 10386040007436 | K792427 | 000 |