The following data is part of a premarket notification filed by Suzhou Colour-way Enterprise Development Co., Ltd. with the FDA for M. Dior Brand.
| Device ID | K083817 |
| 510k Number | K083817 |
| Device Name: | M. DIOR BRAND |
| Classification | Condom |
| Applicant | SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD. RM. 1606, BLDG. 1, JIANXIANG - YUAN NO.209 BEI SI HUAN ZHONG Haidian District, Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD. RM. 1606, BLDG. 1, JIANXIANG - YUAN NO.209 BEI SI HUAN ZHONG Haidian District, Beijing, CN 100083 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2009-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06925634002258 | K083817 | 000 |
| 06925634004511 | K083817 | 000 |
| 06925634004061 | K083817 | 000 |
| 06925634004078 | K083817 | 000 |
| 06925634004085 | K083817 | 000 |
| 06925634004092 | K083817 | 000 |
| 06925634004030 | K083817 | 000 |
| 06925634004054 | K083817 | 000 |
| 00692563400122 | K083817 | 000 |
| 06925634004504 | K083817 | 000 |