The following data is part of a premarket notification filed by Itl Corporation, Pty Ltd. with the FDA for Leespec Disposable Vaginal Speculum.
| Device ID | K021017 |
| 510k Number | K021017 |
| Device Name: | LEESPEC DISPOSABLE VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | ITL CORPORATION, PTY LTD. 41-45 TENNANT ST. Fyshwick, Canberra Act, AU 2609 |
| Contact | William L Mobbs |
| Correspondent | William L Mobbs ITL CORPORATION, PTY LTD. 41-45 TENNANT ST. Fyshwick, Canberra Act, AU 2609 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-29 |
| Decision Date | 2002-06-19 |
| Summary: | summary |