The following data is part of a premarket notification filed by Acecodent, Inc. with the FDA for Amalgamator.
Device ID | K880993 |
510k Number | K880993 |
Device Name: | AMALGAMATOR |
Classification | Amalgamator, Dental, Ac-powered |
Applicant | ACECODENT, INC. 41-80 PARSONS BLVD. Flushing, NY 11355 |
Contact | James Hwang |
Correspondent | James Hwang ACECODENT, INC. 41-80 PARSONS BLVD. Flushing, NY 11355 |
Product Code | EFD |
CFR Regulation Number | 872.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-08 |
Decision Date | 1988-05-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AMALGAMATOR 86430607 4751991 Live/Registered |
BEACHWOOD BLENDERY, LLC 2014-10-22 |
AMALGAMATOR 78191483 not registered Dead/Abandoned |
Berarducci, James D. 2002-12-05 |