The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Du Pont Aca Nev/eev Verifier.
Device ID | K930501 |
510k Number | K930501 |
Device Name: | DU PONT ACA NEV/EEV VERIFIER |
Classification | Calibrator, Primary |
Applicant | DUPONT MEDICAL PRODUCTS BMP 22/1168 Wilmington, DE 19880 |
Contact | Christopher Bentsen |
Correspondent | Christopher Bentsen DUPONT MEDICAL PRODUCTS BMP 22/1168 Wilmington, DE 19880 |
Product Code | JIS |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-01 |
Decision Date | 1993-08-09 |