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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K883384
Device Name TS1000 SUCTION TIP
Applicant
M.D. ENGINEERING, INC.
2536 BARRINGTON COURT
HAYWARD,  CA  94545
Applicant Contact LASH, M.D.
Correspondent
M.D. ENGINEERING, INC.
2536 BARRINGTON COURT
HAYWARD,  CA  94545
Correspondent Contact LASH, M.D.
Regulation Number868.6810
Classification Product Code
BSY  
Date Received08/09/1988
Decision Date 11/02/1988
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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