The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Cytoguide For Use W/the Philmedisyst Mammodiag Uc.
Device ID | K896609 |
510k Number | K896609 |
Device Name: | CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC |
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 | 1989-08-09 |
Decision Date | 1990-01-31 |