FDA 510(k) Application Details - K951882

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K951882
Device Name Generator, Oxygen, Portable
Applicant AIRSEP CORP.
290 CREEKSIDE DR.
BUFFALO, NY US
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Contact EWWARD E VRANA
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 04/03/1995
Decision Date 10/16/1995
Decision SE - Substantially Equivalent
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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