FDA 510(k) Application Details - K952103

Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)

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510(K) Number K952103
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant AEROS INSTRUMENTS, INC.
1111 LAKESIDE DR.
GURNEE, IL US
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Contact CHRIS GOSSETT
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Regulation Number 878.4780

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Classification Product Code BTA
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Date Received 05/04/1995
Decision Date 07/31/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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