The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Medi-therm.
| Device ID | K800812 |
| 510k Number | K800812 |
| Device Name: | MEDI-THERM |
| Classification | System, Thermal Regulating |
| Applicant | GAYMAR INDUSTRIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-11 |
| Decision Date | 1980-04-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MEDI-THERM 85153386 4183865 Dead/Cancelled |
Stryker Corporation 2010-10-15 |
![]() MEDI-THERM 75561826 2294433 Live/Registered |
STRYKER CORPORATION 1998-09-29 |
![]() MEDI-THERM 74562360 not registered Dead/Abandoned |
Mansfield Medical Products USA 1994-08-18 |
![]() MEDI-THERM 73485987 not registered Dead/Abandoned |
GAYMAR INDUSTRIES, INC. 1984-06-19 |
![]() MEDI-THERM 73293960 not registered Dead/Abandoned |
GAYMAR INDUSTRIES, INC. 1981-01-22 |