The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Surgita/mizho Microneurosurgery Head Fr.
| Device ID | K821772 |
| 510k Number | K821772 |
| Device Name: | SURGITA/MIZHO MICRONEUROSURGERY HEAD FR |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | DOWNS SURGICAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-16 |
| Decision Date | 1982-09-28 |