The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Medical Corporation Express Chest Drain.
| Device ID | K984496 |
| 510k Number | K984496 |
| Device Name: | ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN |
| Classification | Bottle, Collection, Vacuum |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Contact | Joseph P Depaolo |
| Correspondent | Joseph P Depaolo ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Product Code | KDQ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-17 |
| Decision Date | 1999-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20650862164002 | K984496 | 000 |
| 20650862161001 | K984496 | 000 |