The following data is part of a premarket notification filed by Neurodynamics, Inc. with the FDA for Modification To Ghajar Guide Twist Drill.
| Device ID | K932402 |
| 510k Number | K932402 |
| Device Name: | MODIFICATION TO GHAJAR GUIDE TWIST DRILL |
| Classification | Drills, Burrs, Trephines & Accessories (manual) |
| Applicant | NEURODYNAMICS, INC. P.O. BOX 603, LENOX HILL STATION New York, NY 10021 |
| Contact | Fathali Ghahremani |
| Correspondent | Fathali Ghahremani NEURODYNAMICS, INC. P.O. BOX 603, LENOX HILL STATION New York, NY 10021 |
| Product Code | HBG |
| CFR Regulation Number | 882.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-21 |
| Decision Date | 1993-08-05 |