FDA 510(k) Application Details - K974066

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K974066
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant MICROLINE PENTAX, INC.
181 ELLIOT ST.
SUITE 915
BEVERLY, MA 01915 US
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Contact HUGHES DE LAFORCADE
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 10/27/1997
Decision Date 01/22/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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