FDA 510(k) Application Details - K963305

Device Classification Name Unit, Electrosurgical Andcoagulation, With Accessories

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510(K) Number K963305
Device Name Unit, Electrosurgical Andcoagulation, With Accessories
Applicant ALEXANDER MFG. CO.
1511 S GARFIELD PL
MASON CITY, IA 50401 US
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Contact STACEY HIPPEN
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Regulation Number 878.4400

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Classification Product Code BWA
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Date Received 08/22/1996
Decision Date 04/17/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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