The following data is part of a premarket notification filed by Halyard Health, Inc. with the FDA for Coolief Cooled Radiofrequency Kit.
| Device ID | K163236 |
| 510k Number | K163236 |
| Device Name: | COOLIEF Cooled Radiofrequency Kit |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | Halyard Health, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Contact | Mary Ann B Kinard |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-11-17 |
| Decision Date | 2016-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00193493469420 | K163236 | 000 |
| 00193493469390 | K163236 | 000 |
| 00193493469383 | K163236 | 000 |
| 00193493469369 | K163236 | 000 |
| 00193493469352 | K163236 | 000 |
| 00193493469345 | K163236 | 000 |
| 00193493469338 | K163236 | 000 |
| 00193493469321 | K163236 | 000 |
| 00193493469291 | K163236 | 000 |