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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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DIANA PRESTON
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Regulation Number
880.6740
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Classification Product Code
GCX
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More FDA Info for this Product Code
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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