The following data is part of a premarket notification filed by S & S Inficon, Inc. with the FDA for Exposet.
Device ID | K922977 |
510k Number | K922977 |
Device Name: | EXPOSET |
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 | 1992-06-17 |
Decision Date | 1992-11-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EXPOSET 74451800 1855611 Dead/Cancelled |
INFIMED, INC. 1993-10-28 |