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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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More FDA Info for this Product Code
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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