FDA 510(k) Application Details - K012928

Device Classification Name Percussor, Powered-Electric

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510(K) Number K012928
Device Name Percussor, Powered-Electric
Applicant ADVANCED RESPIRATORY
1020 WEST COUNTY RD. F
ST. PAUL, MN 55126 US
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Contact ERIC J LARSON
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Regulation Number 868.5665

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Classification Product Code BYI
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Date Received 08/31/2001
Decision Date 10/09/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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