The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Edrain Chest Drainage System.
Device ID | K130131 |
510k Number | K130131 |
Device Name: | EDRAIN CHEST DRAINAGE SYSTEM |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR Hudson, NH 03051 |
Contact | Christina Calderwood |
Correspondent | Christina Calderwood ATRIUM MEDICAL CORP. 5 WENTWORTH DR Hudson, NH 03051 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-18 |
Decision Date | 2013-02-28 |