The following data is part of a premarket notification filed by Mizuho America, Inc. with the FDA for Mizuho Radiolucent Head Frame.
| Device ID | K955012 |
| 510k Number | K955012 |
| Device Name: | MIZUHO RADIOLUCENT HEAD FRAME |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | MIZUHO AMERICA, INC. 123 BRIMBAL AVE. Beverly, MA 01915 |
| Contact | Lisa Schweitzer |
| Correspondent | Lisa Schweitzer MIZUHO AMERICA, INC. 123 BRIMBAL AVE. Beverly, MA 01915 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-01 |
| Decision Date | 1996-09-12 |
| Summary: | summary |