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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 K082276
Device Name SYNTHEMED DEVICE
Applicant
Synthemed, Inc.
200 Middlesex Essex Tpk.
Suite 210
Iselin,  NJ  08830
Applicant Contact ELI PINES
Correspondent
Synthemed, Inc.
200 Middlesex Essex Tpk.
Suite 210
Iselin,  NJ  08830
Correspondent Contact ELI PINES
Regulation Number874.4780
Classification Product Code
LYA  
Date Received08/11/2008
Decision Date 11/18/2008
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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