The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Du Pont Identification Camera.
Device ID | K910354 |
510k Number | K910354 |
Device Name: | DU PONT IDENTIFICATION CAMERA |
Classification | System, X-ray, Film Marking, Radiographic |
Applicant | DUPONT MEDICAL PRODUCTS DIAGNOSTICS & BIOTECHNOLOGY SYSTEMS DIVISION Wilmington, DE 19880 |
Contact | Richard M Vaught |
Correspondent | Richard M Vaught DUPONT MEDICAL PRODUCTS DIAGNOSTICS & BIOTECHNOLOGY SYSTEMS DIVISION Wilmington, DE 19880 |
Product Code | JAC |
CFR Regulation Number | 892.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-29 |
Decision Date | 1991-03-29 |