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510(k) K003076

MITEK CUFFTACK by Mitek Products — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2000
Date Received
October 3, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K002406 — MITEK 2GII MENISCAL REPAIR SYSTEM (February 15, 2001)
  • K002402 — VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM (August 31, 2000)
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  • K000936 — VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM (April 19, 2000)
  • K993575 — RESOLVE QUICKANCHOR (December 29, 1999)
  • K993327 — TALON ANCHOR SNAP-PAK (December 16, 1999)

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