The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Modified Rongeurs For Spinal & Orth. S..
| Device ID | K821358 |
| 510k Number | K821358 |
| Device Name: | MODIFIED RONGEURS FOR SPINAL & ORTH. S. |
| Classification | Forceps, Rongeur, Surgical |
| Applicant | DOWNS SURGICAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EMH |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-06 |
| Decision Date | 1982-05-28 |