The following data is part of a premarket notification filed by Alm Surgical Equipment, Inc. with the FDA for Drager Gemina Wall-mounted Workplace.
| Device ID | K961886 |
| 510k Number | K961886 |
| Device Name: | DRAGER GEMINA WALL-MOUNTED WORKPLACE |
| Classification | Table, Operating-room, Ac-powered |
| Applicant | ALM SURGICAL EQUIPMENT, INC. 1820 NORTH LEMON ST. Anaheim, CA 92801 -1009 |
| Contact | Susan Nielson |
| Correspondent | Susan Nielson ALM SURGICAL EQUIPMENT, INC. 1820 NORTH LEMON ST. Anaheim, CA 92801 -1009 |
| Product Code | FQO |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-15 |
| Decision Date | 1996-07-30 |
| Summary: | summary |