The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Crown, Acrylic, Coral Brand, Preformed.
| Device ID | K770684 |
| 510k Number | K770684 |
| Device Name: | CROWN, ACRYLIC, CORAL BRAND, PREFORMED |
| Classification | Crown, Preformed |
| Applicant | PARKER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELZ |
| CFR Regulation Number | 872.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-04-12 |
| Decision Date | 1977-04-26 |