The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Shepperd Dilatation Tube Set (gs-501-20-h).
| Device ID | K900611 |
| 510k Number | K900611 |
| Device Name: | SHEPPERD DILATATION TUBE SET (GS-501-20-H) |
| Classification | Arthroscope |
| Applicant | DOWNS SURGICAL LTD. PARKWAY CLOSE,PARKWAY INDUSTRIAL ESTATE Sheffield S9 4wj, GB |
| Contact | J Newson |
| Correspondent | J Newson DOWNS SURGICAL LTD. PARKWAY CLOSE,PARKWAY INDUSTRIAL ESTATE Sheffield S9 4wj, GB |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-08 |
| Decision Date | 1990-10-22 |