The following data is part of a premarket notification filed by Chek-med Systems with the FDA for Polar Wand.
| Device ID | K041783 |
| 510k Number | K041783 |
| Device Name: | POLAR WAND |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CHEK-MED SYSTEMS 25 VILLAGE HILL RD. Willington, CT 06279 |
| Contact | Rob Whalen |
| Correspondent | Rob Whalen CHEK-MED SYSTEMS 25 VILLAGE HILL RD. Willington, CT 06279 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-01 |
| Decision Date | 2004-09-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() POLAR WAND 76703163 3906077 Live/Registered |
GI SUPPLY, INC. 2010-05-28 |
![]() POLAR WAND 76703151 3902413 Live/Registered |
GI SUPPLY, INC. 2010-05-28 |