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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K912290
Device Name HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM))
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 Number868.5730
Classification Product Code
BTR  
Date Received05/23/1991
Decision Date 08/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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