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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dissector, Tonsil
510(k) Number K940903
Device Name TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES
Applicant
Medical Insights, Inc.
193 Whitehall Ave.
Mystic,  CT  06355
Applicant Contact ROBERT J CARICATO
Correspondent
Medical Insights, Inc.
193 Whitehall Ave.
Mystic,  CT  06355
Correspondent Contact ROBERT J CARICATO
Regulation Number874.4420
Classification Product Code
KBM  
Date Received02/24/1994
Decision Date 04/14/1994
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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