The following data is part of a premarket notification filed by Seabrook Medical Systems, Inc. with the FDA for Tropi-cool.
Device ID | K902756 |
510k Number | K902756 |
Device Name: | TROPI-COOL |
Classification | System, Thermal Regulating |
Applicant | SEABROOK MEDICAL SYSTEMS, INC. 673 WILMER AVE. Cincinnati, OH 45226 -1859 |
Contact | Mark J Buch |
Correspondent | Mark J Buch SEABROOK MEDICAL SYSTEMS, INC. 673 WILMER AVE. Cincinnati, OH 45226 -1859 |
Product Code | DWJ |
CFR Regulation Number | 870.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-22 |
Decision Date | 1990-10-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TROPI-COOL 87782076 5569347 Live/Registered |
Henry Company, LLC 2018-02-02 |
![]() TROPI-COOL 86094330 4689556 Live/Registered |
Henry Company, LLC 2013-10-17 |
![]() TROPI-COOL 85382879 not registered Dead/Abandoned |
Hawaiian Sun Products, Inc. 2011-07-27 |
![]() TROPI-COOL 78151999 not registered Dead/Abandoned |
Damon Industries 2002-08-07 |
![]() TROPI-COOL 74079085 1757600 Live/Registered |
GENTHERM MEDICAL, LLC 1990-07-17 |
![]() TROPI-COOL 73445819 not registered Dead/Abandoned |
TROPI-COOL 1983-09-29 |
![]() TROPI-COOL 73258749 1171113 Dead/Cancelled |
Kenroy Lighting Corporation 1980-04-21 |