FDA 510(k) Application Details - K991669

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K991669
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant WALLACH SURGICAL DEVICES, INC.
235 EDISON RD.
ORANGE, CT 06477 US
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Contact MICHAEL MALIS
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 05/14/1999
Decision Date 08/12/1999
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 N
Expedited Review



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