The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Wellington Hospital Pattern Self Retaining Vaginal.
| Device ID | K853640 |
| 510k Number | K853640 |
| Device Name: | WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL |
| Classification | Speculum, Vaginal, Metal |
| 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 | HDF |
| CFR Regulation Number | 884.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-20 |
| Decision Date | 1985-10-29 |