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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 K980221
Device Name SILIMED NASAL RETAINER
Applicant
SILIMED, LLC.
P.O BOX 4341
CROFTON,  MD  21114
Applicant Contact E.J. Smith
Correspondent
SILIMED, LLC.
P.O BOX 4341
CROFTON,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number874.4780
Classification Product Code
LYA  
Date Received01/22/1998
Decision Date 04/02/1998
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
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