FDA 510(k) Application Details - K021077

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K021077
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Megadyne Medical Products, Inc.
4545 Creek Road
Cincinnati, OH 45242 US
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Contact Correne Ramy
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 04/03/2002
Decision Date 04/17/2002
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 Y
Expedited Review

FDA Source Information for K021077


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