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 |