The following data is part of a premarket notification filed by Mnlase, Inc. with the FDA for Ors-1000.
| Device ID | K915427 |
| 510k Number | K915427 |
| Device Name: | ORS-1000 |
| Classification | Freezer |
| Applicant | MNLASE, INC. 11250 ROGER BACON DR. #10 Reston, VA 22090 |
| Contact | Bruce Heymann |
| Correspondent | Bruce Heymann MNLASE, INC. 11250 ROGER BACON DR. #10 Reston, VA 22090 |
| Product Code | JRM |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-02 |
| Decision Date | 1992-01-07 |