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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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More FDA Info for this Product Code
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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