The following data is part of a premarket notification filed by Adroit Medical Systems, Inc. with the FDA for Soft-temp.
Device ID | K921920 |
510k Number | K921920 |
Device Name: | SOFT-TEMP |
Classification | System, Thermal Regulating |
Applicant | ADROIT MEDICAL SYSTEMS, INC. P.O. BOX 0984 Morganton, NC 28655 |
Contact | Scott E Gammons |
Correspondent | Scott E Gammons ADROIT MEDICAL SYSTEMS, INC. P.O. BOX 0984 Morganton, NC 28655 |
Product Code | DWJ |
CFR Regulation Number | 870.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-23 |
Decision Date | 1992-12-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SOFT-TEMP 77409995 3532799 Live/Registered |
Adroit Medical Systems, Inc 2008-02-29 |
SOFT-TEMP 74291321 1847297 Dead/Cancelled |
Adroit Medical Systems, Inc. 1992-07-06 |
SOFT-TEMP 74207136 not registered Dead/Abandoned |
Soft-Temp Technologies Ltd. 1991-09-26 |