The following data is part of a premarket notification filed by Neurodynamics, Inc. with the FDA for Ghajar Guide System For The Perforator.
| Device ID | K875019 |
| 510k Number | K875019 |
| Device Name: | GHAJAR GUIDE SYSTEM FOR THE PERFORATOR |
| Classification | Drills, Burrs, Trephines & Accessories (compound, Powered) |
| 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 | HBF |
| CFR Regulation Number | 882.4305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-04 |
| Decision Date | 1988-01-22 |