The following data is part of a premarket notification filed by Forward Science Llc with the FDA for Oralid.
Device ID | K123169 |
510k Number | K123169 |
Device Name: | ORALID |
Classification | Diagnostic Light, Soft Tissue Detector |
Applicant | FORWARD SCIENCE LLC 2511 WIND FALL LN Sugar Land, TX 77479 |
Contact | Brian Pikkula |
Correspondent | Brian Pikkula FORWARD SCIENCE LLC 2511 WIND FALL LN Sugar Land, TX 77479 |
Product Code | NXV |
CFR Regulation Number | 872.6350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-09 |
Decision Date | 2013-03-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00370275123163 | K123169 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ORALID 87605183 5528222 Live/Registered |
Forward Science Holding, Inc. 2017-09-12 |