The following data is part of a premarket notification filed by 3m Company with the FDA for Clinpro Varnish.
Device ID | K151302 |
510k Number | K151302 |
Device Name: | Clinpro Varnish |
Classification | Varnish, Cavity |
Applicant | 3m Company 2510 Conway Avenue St. Paul, MN 55144 -1000 |
Contact | Shari L. Myszka |
Correspondent | Shari L. Myszka 3m Company 2510 Conway Avenue St. Paul, MN 55144 -1000 |
Product Code | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-15 |
Decision Date | 2015-09-18 |
Summary: | summary |