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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 K060815
Device Name JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT
Applicant
Bioform Medical, Inc.
1875 S. Grant St.,Suite 11o
San Mateo,  CA  94402
Applicant Contact JAMES S MILLER
Correspondent
Bioform Medical, Inc.
1875 S. Grant St.,Suite 11o
San Mateo,  CA  94402
Correspondent Contact JAMES S MILLER
Regulation Number874.3620
Classification Product Code
MIX  
Date Received03/27/2006
Decision Date 04/18/2006
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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