The following data is part of a premarket notification filed by Ruggles Corp. with the FDA for Multiple Nonpowered Neurosurgical Instrument.
| Device ID | K902818 |
| 510k Number | K902818 |
| Device Name: | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT |
| Classification | Drills, Burrs, Trephines & Accessories (manual) |
| Applicant | RUGGLES CORP. 38 BILLINGS RD. No. Quincy, MA 02171 |
| Contact | Alan Ruggles |
| Correspondent | Alan Ruggles RUGGLES CORP. 38 BILLINGS RD. No. Quincy, MA 02171 |
| Product Code | HBG |
| CFR Regulation Number | 882.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-27 |
| Decision Date | 1990-09-20 |