The following data is part of a premarket notification filed by Millicore Ab with the FDA for Millicore Ab Digivent Chest Drainage System.
Device ID | K062302 |
510k Number | K062302 |
Device Name: | MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM |
Classification | Bottle, Collection, Vacuum |
Applicant | MILLICORE AB 49 PLAIN STREET North Attleboro, MA 02760 |
Contact | Rosina Robinson |
Correspondent | Rosina Robinson MILLICORE AB 49 PLAIN STREET North Attleboro, MA 02760 |
Product Code | KDQ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-08 |
Decision Date | 2006-10-06 |
Summary: | summary |