The following data is part of a premarket notification filed by L.d. Caulk Co. with the FDA for Lip & Cheek Retractor.
| Device ID | K771399 |
| 510k Number | K771399 |
| Device Name: | LIP & CHEEK RETRACTOR |
| Classification | Retractor, All Types |
| Applicant | L.D. CAULK CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EIG |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-07-29 |
| Decision Date | 1977-08-26 |