The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Ototome Bur.
| Device ID | K792028 |
| 510k Number | K792028 |
| Device Name: | OTOTOME BUR |
| Classification | Bur, Ear, Nose And Throat |
| Applicant | AMERICAN STERILIZER CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EQJ |
| CFR Regulation Number | 874.4140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-09 |
| Decision Date | 1979-10-26 |