The following data is part of a premarket notification filed by S & S Inficon, Inc. with the FDA for Fc2000.
Device ID | K911454 |
510k Number | K911454 |
Device Name: | FC2000 |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | S & S INFICON, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
Contact | Timothy A Kerrigan |
Correspondent | Timothy A Kerrigan S & S INFICON, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-03 |
Decision Date | 1991-07-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FC2000 74718249 1995417 Dead/Cancelled |
InfiMed, Inc. 1995-08-21 |