The following data is part of a premarket notification filed by Columbus Dental Mfg. Co. with the FDA for Shur Gel.
Device ID | K830083 |
510k Number | K830083 |
Device Name: | SHUR GEL |
Classification | Material, Impression |
Applicant | COLUMBUS DENTAL MFG. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-11 |
Decision Date | 1983-02-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SHUR GEL 74576685 1967865 Dead/Cancelled |
MILES INC. 1994-09-22 |