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 |