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510(k) K011105

SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE by Qrc Consulting — Product Code GAL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2001
Date Received
April 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Natural
Device Class
Class II
Regulation Number
878.4830
Review Panel
SU
Submission Type

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