The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for High-pressure Connector Tube.
Device ID | K904212 |
510k Number | K904212 |
Device Name: | HIGH-PRESSURE CONNECTOR TUBE |
Classification | Injector And Syringe, Angiographic |
Applicant | MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
Contact | David E Brown |
Correspondent | David E Brown MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
Product Code | DXT |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-12 |
Decision Date | 1990-12-03 |