Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K150454
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
More FDA Info for this Device
510(K) Number
K150454
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
PERFLEX
7 GIBOREY ISRAEL ST., INDUSTRIAL AREA POLEG
NETANYA 4250407 IL
Other 510(k) Applications for this Company
Contact
RAY KELLY
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
02/20/2015
Decision Date
05/26/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact