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 |