The following data is part of a premarket notification filed by Marketing Perspectives with the FDA for Medisul Disposable Vaginal Speculum.
| Device ID | K000414 |
| 510k Number | K000414 |
| Device Name: | MEDISUL DISPOSABLE VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | MARKETING PERSPECTIVES 6565 146TH AVE. Holland, MI 49423 |
| Contact | Jimmie D Wilson |
| Correspondent | Jimmie D Wilson MARKETING PERSPECTIVES 6565 146TH AVE. Holland, MI 49423 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-08 |
| Decision Date | 2000-04-04 |