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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Larynx (Stents And Keels)
510(k) Number K091135
FOIA Releasable 510(k) K091135
Device Name RUTTER SUPRA STOMAL STENTS
Applicant
Boston Medical Products, Inc.
117 Flanders Rd.
Westborough,  MA  01581
Applicant Contact MICHAEL A WARREN
Correspondent
Boston Medical Products, Inc.
117 Flanders Rd.
Westborough,  MA  01581
Correspondent Contact MICHAEL A WARREN
Regulation Number874.3620
Classification Product Code
FWN  
Date Received04/20/2009
Decision Date 09/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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