FDA 510(k) Application Details - K982063

Device Classification Name Light, Surgical, Ceiling Mounted

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510(K) Number K982063
Device Name Light, Surgical, Ceiling Mounted
Applicant ALM SURGICAL EQUIPMENT, INC.
1820 NORTH LEMON ST.
ANAHEIM, CA 92801-1009 US
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Contact SUSAN NIELSEN
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Regulation Number 878.4580

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Classification Product Code FSY
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Date Received 06/12/1998
Decision Date 09/22/1998
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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