The following data is part of a premarket notification filed by Gammex, Inc. with the FDA for Courier Ii.
Device ID | K953514 |
510k Number | K953514 |
Device Name: | COURIER II |
Classification | System, Digital Image Communications, Radiological |
Applicant | GAMMEX, INC. 2500 WEST BELTLINE HWY. P.O. BOX 620327 Middleton, WI 53562 -0327 |
Contact | Thomas A Demke |
Correspondent | Thomas A Demke GAMMEX, INC. 2500 WEST BELTLINE HWY. P.O. BOX 620327 Middleton, WI 53562 -0327 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-26 |
Decision Date | 1995-10-07 |