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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 K972076
Device Name EPI-MAX EPISTAXIS CATHETER
Applicant
Boston Medical Products, Inc.
117 Flanders Rd.
Westborough,  MA  01581
Applicant Contact STUART K MONTGOMERY
Correspondent
Boston Medical Products, Inc.
117 Flanders Rd.
Westborough,  MA  01581
Correspondent Contact STUART K MONTGOMERY
Regulation Number874.4100
Classification Product Code
EMX  
Date Received06/03/1997
Decision Date 06/26/1997
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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