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510(k) K101462

ASCEND BLUE AC MESH; ASCEND BLUE PC MESH by Caldera Medical, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2010
Date Received
May 26, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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