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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
510(k) Number K013243
Device Name COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
Applicant
BIOFORM, INC.
4133 COURTNEY ROAD, #10
FRANKSVILLE,  WI  53126
Applicant Contact VICTOR M BOWERS
Correspondent
BIOFORM, INC.
4133 COURTNEY ROAD, #10
FRANKSVILLE,  WI  53126
Correspondent Contact VICTOR M BOWERS
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received09/28/2001
Decision Date 01/09/2002
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
Recalls CDRH Recalls
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