FDA 510(k) Application Details - K974553

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K974553
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant 3M HEALTH CARE
3M CENTER, BLDG. 275-3E-08
P.O. BOX 33275
ST. PAUL, MN 55133-1000 US
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Contact LINDA JOHNSEN
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 11/17/1997
Decision Date 02/03/1998
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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