FDA 510(k) Application Details - K201833

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K201833
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant BiPad Surgical, Inc.
110 Ocean Blvd
Point Lookout, NY 11569 US
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Contact Louis Cornacchia
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 07/02/2020
Decision Date 07/31/2020
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



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