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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 K952207
Device Name NASAL SEPTAL SPLINT
Applicant
Smith & Nephew Richards, Inc.
2925 Appling Rd.
Bartlett,  TN  38133
Applicant Contact ALICIA FARAGE
Correspondent
Smith & Nephew Richards, Inc.
2925 Appling Rd.
Bartlett,  TN  38133
Correspondent Contact ALICIA FARAGE
Regulation Number874.4780
Classification Product Code
LYA  
Date Received05/10/1995
Decision Date 06/07/1995
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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