FDA 510(k) Application Details - K972140

Device Classification Name Rhinoanemometer (Measurement Of Nasal Decongestion)

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510(K) Number K972140
Device Name Rhinoanemometer (Measurement Of Nasal Decongestion)
Applicant G.M. INSTRUMENTS LTD.
UNIT 6, ASHGROVE
ASHGROVE ROAD
KILWINNING KA13 6PU GB
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Contact E. W GREIG
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Regulation Number 868.1800

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Classification Product Code BXQ
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Date Received 06/06/1997
Decision Date 09/30/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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