The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Proplus System.
Device ID | K963766 |
510k Number | K963766 |
Device Name: | 3M PROPLUS SYSTEM |
Classification | Material, Impression |
Applicant | 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
Contact | Amy Fowler |
Correspondent | Amy Fowler 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-19 |
Decision Date | 1996-10-31 |
Summary: | summary |