510(k) K152538

JRP Wound Spreader by J.R. Parker, LLC — Product Code GAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2016
Date Received
September 4, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type