The following data is part of a premarket notification filed by Paxman Coolers Limited with the FDA for Paxman Scalp Cooler.
| Device ID | K173032 |
| 510k Number | K173032 |
| Device Name: | Paxman Scalp Cooler |
| Classification | Scalp Cooling System |
| Applicant | Paxman Coolers Limited International House, Penistone Road, Fenay Bridge Huddersfield, GB Hd8 0le |
| Contact | Richard Paxman |
| Correspondent | Heather Crawford Emergo Global Consulting, LLC 2500 Bee Cave Road Builiding 1, Suite 300 Austin, TX 78746 |
| Product Code | PMC |
| CFR Regulation Number | 878.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2018-06-07 |
| Summary: | summary |