The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Tr System.
Device ID | K992489 |
510k Number | K992489 |
Device Name: | 3M TR SYSTEM |
Classification | Powder, Porcelain |
Applicant | 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
Contact | Lael J Pickett |
Correspondent | Lael J Pickett 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-26 |
Decision Date | 2000-01-11 |
Summary: | summary |