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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 K884944
Device Name TU SUCTIONTRAP
Applicant
Tulan Corp. C/O Richard Hamer Assoc.
241 NE 199 Ln.
North Miami Beach,  FL  33179
Applicant Contact TU, M.D.
Correspondent
Tulan Corp. C/O Richard Hamer Assoc.
241 NE 199 Ln.
North Miami Beach,  FL  33179
Correspondent Contact TU, M.D.
Regulation Number868.6810
Classification Product Code
BSY  
Date Received11/25/1988
Decision Date 02/03/1989
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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