The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Malleable Ptfe Coated Brain Spatulae.
| Device ID | K880278 |
| 510k Number | K880278 |
| Device Name: | MALLEABLE PTFE COATED BRAIN SPATULAE |
| Classification | Instrument, Surgical, Non-powered |
| Applicant | DOWNS SURGICAL LTD. PARKWAY CLOSE,PARKWAY INDUSTRIAL ESTATE Sheffield S9 4wj, GB |
| Contact | Geoffrey W Down |
| Correspondent | Geoffrey W Down DOWNS SURGICAL LTD. PARKWAY CLOSE,PARKWAY INDUSTRIAL ESTATE Sheffield S9 4wj, GB |
| Product Code | HAO |
| CFR Regulation Number | 882.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-22 |
| Decision Date | 1988-02-11 |