The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Hand Reamers.
| Device ID | K770203 |
| 510k Number | K770203 |
| Device Name: | HAND REAMERS |
| Classification | Reamer |
| Applicant | DEPUY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HTO |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-01-31 |
| Decision Date | 1977-02-08 |