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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name polymer, ent synthetic-polyamide (mesh or foil material)
510(k) Number K953013
Device Name MEROCEL REINFORCED SILICONE SHEETS
Applicant
MEROCEL CORP.
6743 SOUTHPOINT DRIVE NORTH
JACKSONVILLE,  FL  32216
Applicant Contact DAVID TIMLIN
Correspondent
MEROCEL CORP.
6743 SOUTHPOINT DRIVE NORTH
JACKSONVILLE,  FL  32216
Correspondent Contact DAVID TIMLIN
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received06/29/1995
Decision Date 08/29/1995
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
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