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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K933350
Device Name THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM
Applicant
Therex Corp.
1600 Providence Hwy.
Walpole,  MA  02081
Applicant Contact BRADLEY J ENEGREN
Correspondent
Therex Corp.
1600 Providence Hwy.
Walpole,  MA  02081
Correspondent Contact BRADLEY J ENEGREN
Regulation Number880.5965
Classification Product Code
LJT  
Date Received07/09/1993
Decision Date 02/23/1994
Decision Substantially Equivalent - Kit (SESK)
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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