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 |