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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 K934802
Device Name THEREX LOW-PROFILE PORT-TITANIUM
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 Received10/07/1993
Decision Date 03/22/1994
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
Recalls CDRH Recalls
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