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510(k) K101218

PATCHASSIST by Polytouch Medical, Ltd. — Product Code ORQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 17, 2010
Date Received: April 30, 2010
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mesh, Surgical, Deployer
Device Class: Class II
Regulation Number: 878.3300
Review Panel: SU
Submission Type

Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair).