The following data is part of a premarket notification filed by Sunny Medical Device (shenzhen) Co., Ltd with the FDA for Sunmed Guide Wire.
| Device ID | K120119 |
| 510k Number | K120119 |
| Device Name: | SUNMED GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-17 |
| Decision Date | 2012-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06947358535843 | K120119 | 000 |
| 06947358535812 | K120119 | 000 |
| 06947358535751 | K120119 | 000 |
| 06947358535713 | K120119 | 000 |
| 06947358535508 | K120119 | 000 |
| 06947358535317 | K120119 | 000 |
| 06947358535539 | K120119 | 000 |