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510(k) K192966

FlowMet by Laser Associated Sciences, Inc. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2020
Date Received
October 23, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

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