FDA 510(k) Application Details - K972072

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K972072
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant ELLMAN INTL., INC.
1135 RAILROAD AVE.,
ELLMAN BLDG.
HEWLETT, NY 11557 US
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Contact FRANK LIN
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 06/03/1997
Decision Date 06/19/1997
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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