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FDA 510(k) Application Details - K033503
Device Classification Name
Apparatus, Gas-Scavenging
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510(K) Number
K033503
Device Name
Apparatus, Gas-Scavenging
Applicant
ACCUTRON, INC.
13605 WEST 7TH AVENUE
GOLDEN, CO 80401-4604 US
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Contact
ROBERT N CLARK
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Regulation Number
868.5430
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Classification Product Code
CBN
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More FDA Info for this Product Code
Date Received
11/05/2003
Decision Date
03/12/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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