FDA 510(k) Application Details - K971390

Device Classification Name Table, Operating-Room, Electrical

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510(K) Number K971390
Device Name Table, Operating-Room, Electrical
Applicant STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 US
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Contact LORI HALLER
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Regulation Number 878.4960

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Classification Product Code GDC
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Date Received 04/14/1997
Decision Date 05/15/1997
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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