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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K894131
Device Name DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000
Applicant
THERMEDICS, INC.
470 WILDWOOD ST.
P.O. BOX 2697
WOBURN,  MA  01888 -2697
Applicant Contact ROWLAND WILLIAMS
Correspondent
THERMEDICS, INC.
470 WILDWOOD ST.
P.O. BOX 2697
WOBURN,  MA  01888 -2697
Correspondent Contact ROWLAND WILLIAMS
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/13/1989
Decision Date 09/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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