The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Cll- V1 Light Source.
| Device ID | K130819 |
| 510k Number | K130819 |
| Device Name: | CLL- V1 LIGHT SOURCE |
| Classification | Led Light Source |
| Applicant | OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PKWAY Center Valley, PA 18034 -0610 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PKWAY Center Valley, PA 18034 -0610 |
| Product Code | NTN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-25 |
| Decision Date | 2013-06-19 |
| Summary: | summary |