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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Intranasal Septal
510(k) Number K981374
Device Name POREX NOSTRIL RETAINERS
Applicant
Porex Surgical, Inc.
4715 Roosevelt Hwy.
College Park,  GA  30349 -2417
Applicant Contact HOWARD A MERCER
Correspondent
Porex Surgical, Inc.
4715 Roosevelt Hwy.
College Park,  GA  30349 -2417
Correspondent Contact HOWARD A MERCER
Regulation Number874.4780
Classification Product Code
LYA  
Date Received04/16/1998
Decision Date 07/02/1998
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
Predetermined Change
Control Plan Authorized		 No
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