FDA 510(k) Application Details - K972074

Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered

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510(K) Number K972074
Device Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Applicant WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE, FL 32218-2480 US
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Contact DIANA PRESTON
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Regulation Number 880.6740

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Classification Product Code GCX
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Date Received 06/03/1997
Decision Date 07/25/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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