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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 K951524
Device Name THORACENTESIS CATHETER
Applicant
Baxter Healthcare Corp
1500 Waukegan Rd.
Bldg. K
Mcgaw Park,  IL  60085
Applicant Contact SHARON RICHTER
Correspondent
Baxter Healthcare Corp
1500 Waukegan Rd.
Bldg. K
Mcgaw Park,  IL  60085
Correspondent Contact SHARON RICHTER
Regulation Number880.6740
Classification Product Code
JOL  
Date Received04/03/1995
Decision Date 07/06/1995
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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