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 |