The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Cytoguide.
Device ID | K885020 |
510k Number | K885020 |
Device Name: | CYTOGUIDE |
Classification | System, X-ray, Mammographic |
Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Contact | William G Mcmahon |
Correspondent | William G Mcmahon PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Product Code | IZH |
CFR Regulation Number | 892.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-05 |
Decision Date | 1989-04-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CYTOGUIDE 79076289 3983427 Dead/Cancelled |
Cytoguide ApS 2009-09-18 |
CYTOGUIDE 74247917 1769928 Live/Registered |
TURON MEDTECH AB 1992-02-20 |
CYTOGUIDE 73490315 1377997 Dead/Cancelled |
THYREOS AB 1984-07-17 |