The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Compact 2000.
Device ID | K851892 |
510k Number | K851892 |
Device Name: | COMPACT 2000 |
Classification | Bottle, Collection, Vacuum |
Applicant | ATRIUM MEDICAL CORP. 10 NORTHERN BLVD. Amherst , NH 03031 - |
Contact | Steve Herweck |
Correspondent | Steve Herweck ATRIUM MEDICAL CORP. 10 NORTHERN BLVD. Amherst , NH 03031 - |
Product Code | KDQ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-30 |
Decision Date | 1985-06-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COMPACT 2000 73559535 1405665 Dead/Cancelled |
ATRIUM MEDICAL CORPORATION 1985-09-23 |