FDA 510(k) Application Details - K070090

Device Classification Name System, Vocal Cord Medialization

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510(K) Number K070090
Device Name System, Vocal Cord Medialization
Applicant BIOFORM MEDICAL, INC.
1875 SOUTH GRANT ST.,SUITE 11O
SAN MATEO, CA 94402 US
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Contact JAMES MILLER
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Regulation Number 874.3620

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Classification Product Code MIX
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Date Received 01/10/2007
Decision Date 03/01/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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