FDA 510(k) Application Details - K060331

Device Classification Name Vaporizer, Anesthesia, Non-Heated

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510(K) Number K060331
Device Name Vaporizer, Anesthesia, Non-Heated
Applicant PENLON LIMITED
25 BARKER CLOSE
FISHBOURNE, CHICHESTER
WEST SUSSEX PO18 8BJ GB
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Contact BARRY PEARCE
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Regulation Number 868.5880

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Classification Product Code CAD
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Date Received 02/09/2006
Decision Date 05/10/2006
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 N
Expedited Review



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