The following data is part of a premarket notification filed by Dawnex Industries, Inc. with the FDA for Disposable Plastic Vaginal Speculum.
| Device ID | K903080 |
| 510k Number | K903080 |
| Device Name: | DISPOSABLE PLASTIC VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | DAWNEX INDUSTRIES, INC. 861 PARK AVE. Brooklyn, NY 11206 |
| Contact | William Pymm |
| Correspondent | William Pymm DAWNEX INDUSTRIES, INC. 861 PARK AVE. Brooklyn, NY 11206 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-12 |
| Decision Date | 1990-09-19 |