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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 K993362
Device Name HYLASINE
Applicant
Biomatrix, Inc.
65 Railroad Ave.
Ridgefield,  NJ  07657
Applicant Contact MARIO J RERES
Correspondent
Biomatrix, Inc.
65 Railroad Ave.
Ridgefield,  NJ  07657
Correspondent Contact MARIO J RERES
Regulation Number874.4100
Classification Product Code
EMX  
Date Received10/06/1999
Decision Date 03/13/2000
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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