The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Bisco Led.
Device ID | K052122 |
510k Number | K052122 |
Device Name: | BISCO LED |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
Contact | Benjamin Lichtenwalner |
Correspondent | Benjamin Lichtenwalner BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-08-05 |
Decision Date | 2006-03-29 |
Summary: | summary |