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510(k) K061021

ENTAKE STANDARD AND SAFETY PEG SYSTEM by Conmedcorp — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2006
Date Received
April 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

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  • K020135 — CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF (April 12, 2002)
  • K020186 — CONMED SYSTEM 5000 ESU (April 12, 2002)
  • K002002 — SUREFIT DISPERSIVE ELECTRODE (August 17, 2000)

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