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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 K895502
Device Name MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT
Applicant
Microbio-Medics, Inc.
Post Office Box 2487
Columbus,  MS  39704
Applicant Contact KEITH MCGEE
Correspondent
Microbio-Medics, Inc.
Post Office Box 2487
Columbus,  MS  39704
Correspondent Contact KEITH MCGEE
Regulation Number874.5800
Classification Product Code
EPP  
Date Received09/12/1989
Decision Date 12/08/1989
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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