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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 K051487
Device Name DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
Applicant
DOCTOR'S RESEARCH GROUP, INC.
50 ALTAIR AVE.
PLYMOUTH,  CT  06782
Applicant Contact MAHMUD AHMED
Correspondent
DOCTOR'S RESEARCH GROUP, INC.
50 ALTAIR AVE.
PLYMOUTH,  CT  06782
Correspondent Contact MAHMUD AHMED
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received06/06/2005
Decision Date 12/22/2005
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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