The following data is part of a premarket notification filed by Kunshan Deyi Plastic Co., Ltd. with the FDA for Non-sterile Disposable Vaginal Speculum.
| Device ID | K092870 |
| 510k Number | K092870 |
| Device Name: | NON-STERILE DISPOSABLE VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | KUNSHAN DEYI PLASTIC CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack KUNSHAN DEYI PLASTIC CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-18 |
| Decision Date | 2010-02-16 |
| Summary: | summary |