Device Classification Name |
Resin, Denture, Relining, Repairing, Rebasing
More FDA Info for this Device |
510(K) Number |
K053516 |
Device Name |
Resin, Denture, Relining, Repairing, Rebasing |
Applicant |
PARKELL, INC.
155 SCHMITT BLVD.
P.O. BOX 376
FARMINGDALE, NY 11735 US
Other 510(k) Applications for this Company
|
Contact |
NELSON J GENDUSA
Other 510(k) Applications for this Contact |
Regulation Number |
872.3760
More FDA Info for this Regulation Number |
Classification Product Code |
EBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
12/16/2005 |
Decision Date |
01/26/2006 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
DE - Dental |
Review Advisory Committee |
DE - Dental |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|