The following data is part of a premarket notification filed by Novaprobe Incorporated with the FDA for Novaprobe Led Light Source.
Device ID | K131226 |
510k Number | K131226 |
Device Name: | NOVAPROBE LED LIGHT SOURCE |
Classification | Light Source, Fiberoptic, Routine |
Applicant | NOVAPROBE INCORPORATED 2333W. MAIN STREET SUITE 210 Lansdale, PA 19446 |
Contact | Manish Ingle |
Correspondent | Manish Ingle NOVAPROBE INCORPORATED 2333W. MAIN STREET SUITE 210 Lansdale, PA 19446 |
Product Code | FCW |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-30 |
Decision Date | 2014-07-24 |
Summary: | summary |