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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 K981575
Device Name TYMPANOSTOMY TUBE
Applicant
Grace Medical, Inc.
7715 HWY. 70, SUITE 109
BARTLETT,  TN  38133
Applicant Contact ANTHONY D PRESCOTT
Correspondent
Grace Medical, Inc.
7715 HWY. 70, SUITE 109
BARTLETT,  TN  38133
Correspondent Contact ANTHONY D PRESCOTT
Regulation Number874.3880
Classification Product Code
ETD  
Date Received05/04/1998
Decision Date 07/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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