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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K963867
Device Name NEO-CARE CATHETERIZATION TRAY
Applicant
Klein-Baker Medical, Inc.
12001 Network, Suite 110
San Antonio,  TX  78249
Applicant Contact CLYDE N BAKER
Correspondent
Klein-Baker Medical, Inc.
12001 Network, Suite 110
San Antonio,  TX  78249
Correspondent Contact CLYDE N BAKER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/26/1996
Decision Date 11/06/1996
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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