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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tympanostomy
510(k) Number K062672
Device Name GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
Applicant
Grace Medical, Inc.
8500 WOLF LAKE DR., STE. 110
MEMPHIS,  TN  38133
Applicant Contact JEFF COBB
Correspondent
Grace Medical, Inc.
8500 WOLF LAKE DR., STE. 110
MEMPHIS,  TN  38133
Correspondent Contact JEFF COBB
Regulation Number874.3880
Classification Product Code
ETD  
Date Received09/08/2006
Decision Date 10/24/2006
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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