The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Disposable Vaginal Speculum.
| Device ID | K072942 |
| 510k Number | K072942 |
| Device Name: | MEDLINE DISPOSABLE VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-17 |
| Decision Date | 2008-02-08 |