The following data is part of a premarket notification filed by Hirata Sangyo Co. Usa, Inc. with the FDA for Multiple Manual Surgical Instruments.
| Device ID | K832686 |
| 510k Number | K832686 |
| Device Name: | MULTIPLE MANUAL SURGICAL INSTRUMENTS |
| Classification | Reamer |
| Applicant | HIRATA SANGYO CO. USA, 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 | 1983-08-02 |
| Decision Date | 1983-10-14 |