The following data is part of a premarket notification filed by Promedex, Inc. with the FDA for Varicoscreen(tm).
| Device ID | K900404 |
| 510k Number | K900404 |
| Device Name: | VARICOSCREEN(TM) |
| Classification | System, Thermographic, Liquid Crystal, Nonpowered (adjunctive Use) |
| Applicant | PROMEDEX, INC. C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer PROMEDEX, INC. C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Product Code | KYA |
| CFR Regulation Number | 884.2982 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-29 |
| Decision Date | 1990-12-07 |