FDA 510(k) Application Details - K950613

Device Classification Name Airway, Oropharyngeal, Anesthesiology

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510(K) Number K950613
Device Name Airway, Oropharyngeal, Anesthesiology
Applicant KEISEI (USA) CO., LTD.
23717 HAWTHORNE BLVD., #305
TORRANCE, CA 90505 US
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Contact YUJI FUNAI
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Regulation Number 868.5110

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Classification Product Code CAE
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Date Received 02/10/1995
Decision Date 02/14/1996
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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