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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 K040427
Device Name FIBREX CATHETER PATENCY DEVICE
Applicant
Medical Device Technologies, Inc.
3600 S.W 47th Ave.
Gainesville,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/19/2004
Decision Date 05/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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