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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Catheter And Tip, Suction
510(k) Number K852041
Device Name DEKNATEL THORACIC CATHETER
Applicant
Pfizer, Inc.
235 E. 42nd St.
Ny,  NY  10017
Applicant Contact SHELDON STEINBERG
Correspondent
Pfizer, Inc.
235 E. 42nd St.
Ny,  NY  10017
Correspondent Contact SHELDON STEINBERG
Regulation Number880.6740
Classification Product Code
JOL  
Date Received05/09/1985
Decision Date 06/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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