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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 K934792
Device Name THEREX LOW-PROFILE PORT
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 Received10/06/1993
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
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