FDA 510(k) Application Details - K993668

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

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510(K) Number K993668
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant LAERDAL MEDICAL A/S
TANKE SVILANDSGT. 30
STAVANGER N 4001 NO
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Contact MAGNE STEINSET
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Regulation Number 878.4780

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Classification Product Code BTA
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Date Received 11/01/1999
Decision Date 12/20/1999
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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