The following data is part of a premarket notification filed by Corisen Group, Ltd. with the FDA for Worry-remover Irrigator.
| Device ID | K030056 |
| 510k Number | K030056 |
| Device Name: | WORRY-REMOVER IRRIGATOR |
| Classification | Douche Apparatus, Vaginal, Therapeutic |
| Applicant | CORISEN GROUP, LTD. 6537 MEADOWBROOK COURT West Chester, OH 45069 |
| Contact | Wei N Zuo |
| Correspondent | Wei N Zuo CORISEN GROUP, LTD. 6537 MEADOWBROOK COURT West Chester, OH 45069 |
| Product Code | HED |
| CFR Regulation Number | 884.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-06 |
| Decision Date | 2003-04-22 |
| Summary: | summary |