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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 K935658
Device Name MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT
Applicant
Merocel Corp.
950 Flanders Rd.
Mystic,  CT  06355
Applicant Contact JOHN GAGLIARDI
Correspondent
Merocel Corp.
950 Flanders Rd.
Mystic,  CT  06355
Correspondent Contact JOHN GAGLIARDI
Regulation Number874.4780
Classification Product Code
LYA  
Date Received11/24/1993
Decision Date 03/04/1994
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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