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FDA 510(k) Application Details - K180606
Device Classification Name
Pump, Portable, Aspiration (Manual Or Powered)
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510(K) Number
K180606
Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Applicant
SOMAVAC Medical Solutions, Inc.
20 South Dudley Street, Suite 100
Memphis, TN 38103 US
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Contact
Esra Roan
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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
03/07/2018
Decision Date
05/31/2018
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
N
Expedited Review
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