The following data is part of a premarket notification filed by Keeler Optical Products Ltd. with the FDA for Locator, Foreign Body.
| Device ID | K781892 |
| 510k Number | K781892 |
| Device Name: | LOCATOR, FOREIGN BODY |
| Classification | Locator, Metal, Electronic |
| Applicant | KEELER OPTICAL PRODUCTS LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HPM |
| CFR Regulation Number | 886.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-08 |
| Decision Date | 1978-12-04 |