The following data is part of a premarket notification filed by Eis Corporation with the FDA for Pessary.
| Device ID | K132313 |
| 510k Number | K132313 |
| Device Name: | PESSARY |
| Classification | Pessary, Vaginal |
| Applicant | EIS CORPORATION #821 Samil Plaza, 837-26 Yeuksam-dong Gangnam-gu, Seoul, KR 135-768 |
| Contact | Yang Ho Dong |
| Correspondent | Yang Ho Dong EIS CORPORATION #821 Samil Plaza, 837-26 Yeuksam-dong Gangnam-gu, Seoul, KR 135-768 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-25 |
| Decision Date | 2014-12-05 |
| Summary: | summary |