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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 K991324
Device Name TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)
Applicant
HEINZ KURZ
TUEBINGER STRASSE 3
DUSSLINGEN,  DE D-72144
Applicant Contact DAGMAR S MASER
Correspondent
HEINZ KURZ
TUEBINGER STRASSE 3
DUSSLINGEN,  DE D-72144
Correspondent Contact DAGMAR S MASER
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received04/19/1999
Decision Date 05/18/1999
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
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