510(k) K132526

KNIT-PAK+ by Premier Dental Products Co. — Product Code MVL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2013
Date Received
August 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Retraction
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type