The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Senzzzzz Away.
Device ID | K120176 |
510k Number | K120176 |
Device Name: | SENZZZZZ AWAY |
Classification | Varnish, Cavity |
Applicant | CENTRIX, INC. 11234 EL CAMINO REAL STE 200 San Diego, CA 92130 |
Contact | Linda K Schulz |
Correspondent | Linda K Schulz CENTRIX, INC. 11234 EL CAMINO REAL STE 200 San Diego, CA 92130 |
Product Code | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-20 |
Decision Date | 2012-07-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817051021331 | K120176 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SENZZZZZ AWAY 85239249 4272743 Live/Registered |
Majestic Drug Co. Inc. 2011-02-10 |