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FDA 510(k) Application Details - K060193
Device Classification Name
Gas-Machine, Anesthesia
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510(K) Number
K060193
Device Name
Gas-Machine, Anesthesia
Applicant
OCEANIC MEDICAL PRODUCTS, INC.
555 THIRTEENTH STREET, NW.
WASHINGTON, DC 20004 US
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Contact
HOWARD M HOLSTEIN
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Regulation Number
868.5160
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Classification Product Code
BSZ
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More FDA Info for this Product Code
Date Received
01/25/2006
Decision Date
04/10/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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