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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 K944302
Device Name THE FLEX-SET SUBCUTANEOUS INFUSION SET
Applicant
Cathco, Inc.
71 Riverlawn Dr.
Fairhaven,  NJ  07704
Applicant Contact DAVID R FISCHELL
Correspondent
Cathco, Inc.
71 Riverlawn Dr.
Fairhaven,  NJ  07704
Correspondent Contact DAVID R FISCHELL
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/06/1994
Decision Date 04/10/1995
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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