FDA 510(k) Application Details - K972161

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K972161
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant MAXXIM MEDICAL
1070 THORNWOOD LN.
DACULA, GA 30211-3007 US
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Contact MICHAEL A CLARK
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 06/09/1997
Decision Date 06/18/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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