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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Esophageal, Ent
510(k) Number K923355
Device Name PHARYNGEAL SALIVARY BYPASS TUBE
Applicant
Boston Medical Products, Inc.
87 Rumford Ave.
Waltham,  MA  02154
Applicant Contact STUART K MONTGOMERY
Correspondent
Boston Medical Products, Inc.
87 Rumford Ave.
Waltham,  MA  02154
Correspondent Contact STUART K MONTGOMERY
Regulation Number874.4420
Classification Product Code
KCF  
Date Received07/08/1992
Decision Date 10/06/1992
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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