The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Wellington Hospital Pattern Self-retain.
| Device ID | K843388 |
| 510k Number | K843388 |
| Device Name: | WELLINGTON HOSPITAL PATTERN SELF-RETAIN |
| Classification | Speculum, Vaginal, Metal |
| Applicant | DOWNS SURGICAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HDF |
| CFR Regulation Number | 884.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-29 |
| Decision Date | 1984-10-01 |