The following data is part of a premarket notification filed by Kerr Corp. with the FDA for Demetron Lc.
Device ID | K014179 |
510k Number | K014179 |
Device Name: | DEMETRON LC |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | KERR CORP. 1717 WEST COLLINS AVE. Orange, CA 92867 |
Contact | Colleen Boswell |
Correspondent | Colleen Boswell KERR CORP. 1717 WEST COLLINS AVE. Orange, CA 92867 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-12-20 |
Decision Date | 2002-02-04 |
Summary: | summary |