The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Du Pont Compact Daylight System Ii (cds Ii).
Device ID | K924552 |
510k Number | K924552 |
Device Name: | DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II) |
Classification | Processor, Radiographic-film, Automatic |
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 | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-09 |
Decision Date | 1992-12-07 |