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FDA 510(k) Application Details - K103042
Device Classification Name
Pump, Portable, Aspiration (Manual Or Powered)
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510(K) Number
K103042
Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Applicant
ATMOS INC.
3717 HUCKLEBERRY ROAD
ALLENTOWN, PA 18104 US
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Contact
MARCO SCHLEGEL
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Regulation Number
878.4780
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Classification Product Code
BTA
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More FDA Info for this Product Code
Date Received
10/14/2010
Decision Date
04/15/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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