The following data is part of a premarket notification filed by Ferrania S.p.a. with the FDA for Liferay Wl Cassette, Liferay Kw Cassette.
| Device ID | K012373 |
| 510k Number | K012373 |
| Device Name: | LIFERAY WL CASSETTE, LIFERAY KW CASSETTE |
| Classification | Cassette, Radiographic Film |
| Applicant | FERRANIA S.P.A. 57 VIALE DELLA LIBERTA Ferrania, Savona, IT 17014 |
| Contact | Mannela Paolo |
| Correspondent | George Kreiner UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-07-26 |
| Decision Date | 2001-08-09 |
| Summary: | summary |