The following data is part of a premarket notification filed by Ortho Pared Instruments, Inc. with the FDA for Universall Drill Guide.
| Device ID | K820226 |
| 510k Number | K820226 |
| Device Name: | UNIVERSALL DRILL GUIDE |
| Classification | Bit, Drill |
| Applicant | ORTHO PARED INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HTW |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-27 |
| Decision Date | 1982-02-04 |