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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 K942724
Device Name EXTERNAL NASAL SPLINT
Applicant
Micromed Development Corp.
4911 Creekside Dr.
Clearwater,  FL  34620
Applicant Contact DAN H TREACE
Correspondent
Micromed Development Corp.
4911 Creekside Dr.
Clearwater,  FL  34620
Correspondent Contact DAN H TREACE
Regulation Number874.5800
Classification Product Code
EPP  
Date Received06/09/1994
Decision Date 07/08/1994
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
Predetermined Change
Control Plan Authorized		 No
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