The following data is part of a premarket notification filed by Skylark Device & Systems Co., Ltd with the FDA for Skylark Uro Probe.
| Device ID | K053007 |
| 510k Number | K053007 |
| Device Name: | SKYLARK URO PROBE |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | SKYLARK DEVICE & SYSTEMS CO., LTD 4F, 34, SEC. 3, CHUNG SHAN NORTH RD. Taipei, TW 104 |
| Contact | George Chiang |
| Correspondent | George Chiang SKYLARK DEVICE & SYSTEMS CO., LTD 4F, 34, SEC. 3, CHUNG SHAN NORTH RD. Taipei, TW 104 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-26 |
| Decision Date | 2005-12-05 |
| Summary: | summary |