The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Mason Equipment Organizer & Aspen.
| Device ID | K843801 |
| 510k Number | K843801 |
| Device Name: | MASON EQUIPMENT ORGANIZER & ASPEN |
| Classification | Table, Operating-room, Manual |
| Applicant | ASPEN LABORATORIES, INC. P.O. BOX 3936 Englewood, CO 80155 -3936 |
| Contact | Bershok |
| Correspondent | Bershok ASPEN LABORATORIES, INC. P.O. BOX 3936 Englewood, CO 80155 -3936 |
| Product Code | FSE |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-27 |
| Decision Date | 1984-10-25 |