The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Ultra-vision Super Rapid Intensifying Screen.
Device ID | K933161 |
510k Number | K933161 |
Device Name: | ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN |
Classification | Screen, Intensifying, Radiographic |
Applicant | DUPONT MEDICAL PRODUCTS BMP 22/1168 Wilmington, DE 19880 |
Contact | Jean Bartlett |
Correspondent | Jean Bartlett DUPONT MEDICAL PRODUCTS BMP 22/1168 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 | 1993-06-29 |
Decision Date | 1993-10-07 |