The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Tracheal Intubation Fibervideoscope, Models Lf-y0004 And Lf-y0005.
| Device ID | K082720 |
| 510k Number | K082720 |
| Device Name: | TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Stacy Abbatiello Kluesner |
| Correspondent | Stacy Abbatiello Kluesner OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-17 |
| Decision Date | 2008-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170340369 | K082720 | 000 |
| 04953170288661 | K082720 | 000 |
| 04953170288630 | K082720 | 000 |