FDA 510(k), K161330, Pour Acrylic

Contents: Correspondence, Indications for Use, 510K Summary, Acceptance Checklist for Traditional 510ks, Labeling, Medical Device User Fee Cover Sheet, Device Comparison Table, Certification of Compliance, Various Articles 

510(K) Number: K161330
Device Name: Pour Acrylic
Manufacturer: Helen Lewis
Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing
Regulation Number: EBI
Classification Product Code: 05/12/2016
Date Received: 10/06/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental

160 Pages (355 of 515 original pages are fully redacted)