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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 K033398
Device Name LARYNGEAL AUGMENTATION IMPLANT
Applicant
Bioform, Inc.
1875 S. Grant St.,Suite 11o
San Mateo,  CA  94402
Applicant Contact JAMES MILLER
Correspondent
Bioform, Inc.
1875 S. Grant St.,Suite 11o
San Mateo,  CA  94402
Correspondent Contact JAMES MILLER
Regulation Number874.3620
Classification Product Code
MIX  
Date Received10/24/2003
Decision Date 12/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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