The following data is part of a premarket notification filed by Nuell Air Equipment & Hospital Supplies, Inc. with the FDA for Craniotome Blade Or Neuro Blade.
| Device ID | K881418 |
| 510k Number | K881418 |
| Device Name: | CRANIOTOME BLADE OR NEURO BLADE |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | NUELL AIR EQUIPMENT & HOSPITAL SUPPLIES, INC. P.O. BOX 55 Warsaw, IN 46581 -0055 |
| Contact | Darlene Holsclaw |
| Correspondent | Darlene Holsclaw NUELL AIR EQUIPMENT & HOSPITAL SUPPLIES, INC. P.O. BOX 55 Warsaw, IN 46581 -0055 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-04 |
| Decision Date | 1988-05-31 |