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510(k) K002639

BIOKNOTLESS ANCHOR by Mitek Products — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2001
Date Received
August 24, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

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