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FDA 510(k) Application Details - K070090
Device Classification Name
System, Vocal Cord Medialization
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
JAMES MILLER
Other 510(k) Applications for this Contact
Regulation Number
874.3620
More FDA Info for this Regulation Number
Classification Product Code
MIX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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