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FDA 510(k) Application Details - K081718
Device Classification Name
Bottle, Collection, Vacuum
More FDA Info for this Device
510(K) Number
K081718
Device Name
Bottle, Collection, Vacuum
Applicant
ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON, NH 03051 US
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Contact
KAREN HALL
Other 510(k) Applications for this Contact
Regulation Number
880.6740
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Classification Product Code
KDQ
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More FDA Info for this Product Code
Date Received
06/18/2008
Decision Date
07/25/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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