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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, vocal cord medialization
510(k) Number K070090
Device Name RADIESSE LARYNGEAL IMPLANT
Applicant
BIOFORM MEDICAL, INC.
1875 SOUTH GRANT ST.,SUITE 11O
SAN MATEO,  CA  94402
Applicant Contact JAMES MILLER
Correspondent
BIOFORM MEDICAL, INC.
1875 SOUTH GRANT ST.,SUITE 11O
SAN MATEO,  CA  94402
Correspondent Contact JAMES MILLER
Regulation Number874.3620
Classification Product Code
MIX  
Date Received01/10/2007
Decision Date 03/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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