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510(k) K090078

KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT by Iop, Inc. — Product Code NXM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 8, 2009
Date Received: January 12, 2009
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Prosthesis, Eyelid Spacer/Graft, Biologic
Device Class: Class II
Regulation Number: 886.3130
Review Panel: OP
Submission Type

For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid.

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