The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Roller Knife-transverse -sagittal.
| Device ID | K833602 |
| 510k Number | K833602 |
| Device Name: | ROLLER KNIFE-TRANSVERSE -SAGITTAL |
| Classification | Knife, Ear |
| Applicant | MICROTEK MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JYO |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-12 |
| Decision Date | 1984-01-03 |