FDA 510(k) Application Details - K001498

Device Classification Name Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered

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510(K) Number K001498
Device Name Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
Applicant MEDISURG LTD.
100 WEST FORNANCE ST.
THE FUGO BUILDING
NORRISTOWN, PA 19401 US
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Contact RICHARD J FUGO
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Regulation Number 886.4100

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Classification Product Code NCR
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Date Received 05/15/2000
Decision Date 08/10/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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