The following data is part of a premarket notification filed by Hirata Sangyo Co. Usa, Inc. with the FDA for Surgical Instrument.
| Device ID | K833541 |
| 510k Number | K833541 |
| Device Name: | SURGICAL INSTRUMENT |
| Classification | Retractor |
| Applicant | HIRATA SANGYO CO. USA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-27 |
| Decision Date | 1983-11-28 |