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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 K930150
Device Name SAFE-T-TUBE RADIOPAQUE
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 Received01/04/1993
Decision Date 02/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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