FDA 510(k) Application Details - K981966

Device Classification Name Balloon, Epistaxis

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510(K) Number K981966
Device Name Balloon, Epistaxis
Applicant MICHAEL M. KNOTT, M.D.
355 ROSE PINE COURT
PO BOX 5577
TAHOE CITY, CA 96145-5577 US
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Contact MICHAEL M KNOTT
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Regulation Number 874.4100

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Classification Product Code EMX
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Date Received 06/04/1998
Decision Date 08/14/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K981966


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