The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Range Of Neurosurgical Instruments In Titanium.
| Device ID | K873933 |
| 510k Number | K873933 |
| Device Name: | RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM |
| Classification | Instrument, Microsurgical |
| Applicant | DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Contact | Mr. J Forster |
| Correspondent | Mr. J Forster DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Product Code | GZX |
| CFR Regulation Number | 882.4525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-25 |
| Decision Date | 1987-12-17 |