The following data is part of a premarket notification filed by Surgical Mechanical Research, Inc. with the FDA for Clear-view Mirror Warmer.
| Device ID | K800382 |
| 510k Number | K800382 |
| Device Name: | CLEAR-VIEW MIRROR WARMER |
| Classification | Motor, Surgical Instrument, Pneumatic Powered |
| Applicant | SURGICAL MECHANICAL RESEARCH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GET |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-22 |
| Decision Date | 1980-05-14 |