The following data is part of a premarket notification filed by Sunoptic Technologies, Llc with the FDA for Led Light Source.
Device ID | K093792 |
510k Number | K093792 |
Device Name: | LED LIGHT SOURCE |
Classification | Light Source, Fiberoptic, Routine |
Applicant | SUNOPTIC TECHNOLOGIES, LLC 6018 BOWDENDALE AVE. Jacksonville, FL 32216 -6042 |
Contact | Janice G Lee |
Correspondent | Janice G Lee SUNOPTIC TECHNOLOGIES, LLC 6018 BOWDENDALE AVE. Jacksonville, FL 32216 -6042 |
Product Code | FCW |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-10 |
Decision Date | 2010-03-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00843059116694 | K093792 | 000 |
04961333240494 | K093792 | 000 |
04961333233977 | K093792 | 000 |
04961333231096 | K093792 | 000 |
00843059112351 | K093792 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LED LIGHT SOURCE 79200359 5243529 Live/Registered |
Maxell Holdings, Ltd. 2016-09-01 |