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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name capillary blood collection device for alternative site collection
510(k) Number K190225
Device Name TAP Blood Collection Device
Applicant
Seventh Sense Biosystems, Inc.
200 Boston Avenue, Suite 3700
Medford,  MA  02155
Applicant Contact Tim Richards
Correspondent
Seventh Sense Biosystems, Inc.
200 Boston Avenue, Suite 3700
Medford,  MA  02155
Correspondent Contact Tim Richards
Regulation Number862.1675
Classification Product Code
PRJ  
Date Received02/05/2019
Decision Date 11/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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