The following data is part of a premarket notification filed by Astralite Corp. with the FDA for Lfre Indirect Laryngoscope.
| Device ID | K023004 |
| 510k Number | K023004 |
| Device Name: | LFRE INDIRECT LARYNGOSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | ASTRALITE CORP. 7701 WOODLEY AVE. Van Nuys, CA 91406 |
| Contact | Dorian Swartz |
| Correspondent | Dorian Swartz ASTRALITE CORP. 7701 WOODLEY AVE. Van Nuys, CA 91406 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-09 |
| Decision Date | 2003-01-28 |
| Summary: | summary |