The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Dupont Apc Blood Collection Container With Lithium Heparin.
Device ID | K942240 |
510k Number | K942240 |
Device Name: | DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | DUPONT MEDICAL PRODUCTS BARLEY MILL PLAZA P22-1170 Wilmington, DE 19880 -0022 |
Contact | Carolyn K George |
Correspondent | Carolyn K George DUPONT MEDICAL PRODUCTS BARLEY MILL PLAZA P22-1170 Wilmington, DE 19880 -0022 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-09 |
Decision Date | 1994-08-17 |