The following data is part of a premarket notification filed by J.l. Blosser, Inc. with the FDA for Bluewand Led Dental Curing Wand System.
Device ID | K040614 |
510k Number | K040614 |
Device Name: | BLUEWAND LED DENTAL CURING WAND SYSTEM |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | J.L. BLOSSER, INC. 22 NORTH MAIN ST. Liberty, MO 64068 |
Contact | Larry L Blosser |
Correspondent | Larry L Blosser J.L. BLOSSER, INC. 22 NORTH MAIN ST. Liberty, MO 64068 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-03-09 |
Decision Date | 2004-04-07 |
Summary: | summary |