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 |