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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 K960450
Device Name HEBELER SAFE-T-TUBE
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 Number868.5730
Classification Product Code
BTR  
Date Received01/30/1996
Decision Date 04/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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