The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Ocean Chest Drain.
| Device ID | K043582 |
| 510k Number | K043582 |
| Device Name: | OCEAN CHEST DRAIN |
| Classification | Bottle, Collection, Vacuum |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Contact | Joseph P De Paolo |
| Correspondent | Joseph P De Paolo ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Product Code | KDQ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-28 |
| Decision Date | 2005-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20650862104039 | K043582 | 000 |
| 20650862100048 | K043582 | 000 |
| 20650862100062 | K043582 | 000 |
| 20650862100093 | K043582 | 000 |
| 20650862100109 | K043582 | 000 |
| 20650862100192 | K043582 | 000 |
| 20650862100215 | K043582 | 000 |
| 20650862100321 | K043582 | 000 |
| 20650862100345 | K043582 | 000 |
| 20650862101021 | K043582 | 000 |
| 20650862101038 | K043582 | 000 |
| 20650862102011 | K043582 | 000 |
| 20650862102042 | K043582 | 000 |
| 20650862102059 | K043582 | 000 |
| 20650862103018 | K043582 | 000 |
| 20650862103032 | K043582 | 000 |
| 20650862103063 | K043582 | 000 |
| 20650862104015 | K043582 | 000 |
| 20650862100017 | K043582 | 000 |