The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Compact 2000 Water Seal Chest Drainage Unit.
| Device ID | K860023 |
| 510k Number | K860023 |
| Device Name: | COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT |
| Classification | Bottle, Collection, Vacuum |
| Applicant | ATRIUM MEDICAL CORP. 17 CLINTON DR. Hollis, NH 03049 |
| Contact | Ted Karwoski |
| Correspondent | Ted Karwoski ATRIUM MEDICAL CORP. 17 CLINTON DR. Hollis, NH 03049 |
| Product Code | KDQ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-03 |
| Decision Date | 1986-01-10 |