The following data is part of a premarket notification filed by Forward Science Llc with the FDA for Salivamax.
Device ID | K152406 |
510k Number | K152406 |
Device Name: | SalivaMAX |
Classification | Saliva, Artificial |
Applicant | FORWARD SCIENCE LLC 3944 Bluebonnet Dr. Stafford, TX 77477 |
Contact | Brian Pikkula |
Correspondent | Brian Pikkula FORWARD SCIENCE LLC 3944 Bluebonnet Dr. Stafford, TX 77477 |
Product Code | LFD |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-25 |
Decision Date | 2015-12-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00370275629306 | K152406 | 000 |
00370275629122 | K152406 | 000 |
00370275629030 | K152406 | 000 |
00370275629047 | K152406 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SALIVAMAX 87605386 5517379 Live/Registered |
Forward Science Holding, Inc. 2017-09-12 |