FDA 510(k) Application Details - K971988

Device Classification Name Table, Operating-Room, Ac-Powered

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510(K) Number K971988
Device Name Table, Operating-Room, Ac-Powered
Applicant ALLEN MEDICAL SYSTEMS, INC.
15627 NEO PKWY.
CLEVELAND, OH 44128 US
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Contact SUZANNE KAY RATZLOFF
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Regulation Number 878.4960

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Classification Product Code FQO
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Date Received 05/29/1997
Decision Date 07/11/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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