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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
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