The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Dry Suction Control Water Seal Chest Drain.
Device ID | K950677 |
510k Number | K950677 |
Device Name: | ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN |
Classification | Bottle, Collection, Vacuum |
Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
Contact | Ted Karwoski |
Correspondent | Ted Karwoski 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 | 1995-02-14 |
Decision Date | 1995-04-13 |