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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 K944504
Device Name CATCO FIRST PICC
Applicant
Catco Medical, Inc.
9010 Foxland Dr.
San Antonio,  TX  78230
Applicant Contact CLYDE N BAKER
Correspondent
Catco Medical, Inc.
9010 Foxland Dr.
San Antonio,  TX  78230
Correspondent Contact CLYDE N BAKER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/14/1994
Decision Date 03/31/1995
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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