The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Ultra-vision Rapid Intensifying Screen.
Device ID | K920190 |
510k Number | K920190 |
Device Name: | ULTRA-VISION RAPID INTENSIFYING SCREEN |
Classification | Screen, Intensifying, Radiographic |
Applicant | E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
Contact | Richard M Forbis |
Correspondent | Richard M Forbis E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
Product Code | EAM |
CFR Regulation Number | 892.1960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-15 |
Decision Date | 1992-05-28 |