The following data is part of a premarket notification filed by Mnlase, Inc. with the FDA for Ors-2000 Series.
| Device ID | K921633 |
| 510k Number | K921633 |
| Device Name: | ORS-2000 SERIES |
| Classification | Warmer, Irrigation Solution |
| 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 | LHC |
| CFR Regulation Number | 890.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-06 |
| Decision Date | 1992-06-02 |