The following data is part of a premarket notification filed by Diva International Inc with the FDA for The Divacup Menstrual Solution.
| Device ID | K021356 |
| 510k Number | K021356 |
| Device Name: | THE DIVACUP MENSTRUAL SOLUTION |
| Classification | Cup, Menstrual |
| Applicant | DIVA INTERNATIONAL INC P.O. BOX 25089 1375 WEBER STREET E Kitchener Ontario, CA N2a 4a5 |
| Contact | Francine Chambers |
| Correspondent | Francine Chambers DIVA INTERNATIONAL INC P.O. BOX 25089 1375 WEBER STREET E Kitchener Ontario, CA N2a 4a5 |
| Product Code | HHE |
| CFR Regulation Number | 884.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-29 |
| Decision Date | 2002-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857538000244 | K021356 | 000 |
| 00857538000237 | K021356 | 000 |
| 00857538000169 | K021356 | 000 |
| 00857538000152 | K021356 | 000 |
| 00857538000145 | K021356 | 000 |
| 00857538000138 | K021356 | 000 |
| 10857538000043 | K021356 | 000 |
| 10857538000258 | K021356 | 000 |