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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
Applicant Contact ROWLAND WILLIAMS
Correspondent
Thermedics, Inc.
470 Wildwood St.
P.O. Box 2697
Woburn,  MA  01888
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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