The following data is part of a premarket notification filed by Neurodynamics, Inc. with the FDA for Ghajar Guide Twist Drill.
| Device ID | K875018 |
| 510k Number | K875018 |
| Device Name: | 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 | Margaret R Meade |
| Correspondent | Margaret R Meade 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 | 1987-12-04 |
| Decision Date | 1988-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780514749 | K875018 | 000 |
| 10886704035985 | K875018 | 000 |