The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Komai Ct-stereotactic Apparatus And Accessories.
| Device ID | K861629 |
| 510k Number | K861629 |
| Device Name: | KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Contact | John Forster |
| Correspondent | John Forster DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-29 |
| Decision Date | 1986-08-12 |