The following data is part of a premarket notification filed by Engineered Orthopedic Technologies, Inc. with the FDA for Malcolm-rand Microneurosurgical Cranio-xray Frame.
| Device ID | K874298 |
| 510k Number | K874298 |
| Device Name: | MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | ENGINEERED ORTHOPEDIC TECHNOLOGIES, INC. 114-C LOS MOLINOS San Clemente, CA 92672 |
| Contact | Roger J Malcolm |
| Correspondent | Roger J Malcolm ENGINEERED ORTHOPEDIC TECHNOLOGIES, INC. 114-C LOS MOLINOS San Clemente, CA 92672 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-20 |
| Decision Date | 1988-02-04 |