The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Trans-lite.
| Device ID | K920782 |
| 510k Number | K920782 |
| Device Name: | OLYMPIC TRANS-LITE |
| Classification | Light, Examination, Medical, Battery Powered |
| Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Contact | Joseph Stefanile |
| Correspondent | Joseph Stefanile OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Product Code | KYT |
| CFR Regulation Number | 880.6350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-20 |
| Decision Date | 1992-03-27 |