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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 K942412
Device Name THEREX LOW-PROFILE PORT - TITANIUM MODEL
Applicant
THEREX CORP.
1600 PROVIDENCE HIGHWAY
WALPOLE,  MA  02081
Applicant Contact BRADLEY ENEGREN
Correspondent
THEREX CORP.
1600 PROVIDENCE HIGHWAY
WALPOLE,  MA  02081
Correspondent Contact BRADLEY ENEGREN
Regulation Number880.5965
Classification Product Code
LJT  
Date Received05/20/1994
Decision Date 08/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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