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 |