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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 K954449
Device Name ENT PACKINGS, WICKS, WIPES, AND SPONGES
Applicant
Oasis
514 S Vermont Ave.
Glendora,  CA  91741
Applicant Contact JAMES CHRISTENSEN
Correspondent
Oasis
514 S Vermont Ave.
Glendora,  CA  91741
Correspondent Contact JAMES CHRISTENSEN
Regulation Number874.4780
Classification Product Code
LYA  
Date Received08/25/1995
Decision Date 11/14/1995
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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