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 |