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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name splint, nasal
510(k) Number K862496
Device Name MICROTEK INTRANASAL SPLINT
Applicant
MICROTEK MEDICAL, INC.
POST OFFICE BOX 2487
COLUMBUS,  MS  39704
Applicant Contact FRANK LOCKHART
Correspondent
MICROTEK MEDICAL, INC.
POST OFFICE BOX 2487
COLUMBUS,  MS  39704
Correspondent Contact FRANK LOCKHART
Regulation Number874.5800
Classification Product Code
EPP  
Date Received07/01/1986
Decision Date 07/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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