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FDA 510(k) Application Details - K052335
Device Classification Name
Gas-Machine, Anesthesia
More FDA Info for this Device
510(K) Number
K052335
Device Name
Gas-Machine, Anesthesia
Applicant
ACCUTRON, INC.
13605 WEST 7TH AVENUE
GOLDEN, CO 80401-4604 US
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Contact
ROBERT N CLARK
Other 510(k) Applications for this Contact
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
08/26/2005
Decision Date
11/23/2005
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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