FDA 510(k) Application Details - K952587

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K952587
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant CYTOCARE, INC.
100 COLUMBIA
SUITE 100
ALISO VIEJO, CA US
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Contact PAUL MIKUS
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 06/05/1995
Decision Date 07/17/1995
Decision SE - Substantially Equivalent
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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