The following data is part of a premarket notification filed by Conphar, Inc. with the FDA for Pederson Vaginal Specula.
| Device ID | K821291 |
| 510k Number | K821291 |
| Device Name: | PEDERSON VAGINAL SPECULA |
| Classification | Speculum, Vaginal, Metal |
| Applicant | CONPHAR, INC. 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 | 1982-05-04 |
| Decision Date | 1982-05-24 |