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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 K925373
Device Name THEREX LOW-PROFILE PORT/1.0MM I.D./1.8MM O.D
Applicant
THEREX CORP.
1600 PROVIDENCE HIGHWAY
WALPOLE,  MA  02081
Applicant Contact BRADLEY J ENEGREN
Correspondent
THEREX CORP.
1600 PROVIDENCE HIGHWAY
WALPOLE,  MA  02081
Correspondent Contact BRADLEY J ENEGREN
Regulation Number880.5965
Classification Product Code
LJT  
Date Received10/23/1992
Decision Date 05/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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