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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Balloon, Epistaxis
510(k) Number K920394
Device Name MEROCEL EPISTACIS KIT
Applicant
Merocel Corp.
950 Flanders Rd.
Mystic,  CT  06355
Applicant Contact DOUGLAS R VALENTINE
Correspondent
Merocel Corp.
950 Flanders Rd.
Mystic,  CT  06355
Correspondent Contact DOUGLAS R VALENTINE
Regulation Number874.4100
Classification Product Code
EMX  
Date Received01/30/1992
Decision Date 03/18/1993
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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