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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K002767
Device Name COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE
Applicant
Semler Technologies, Inc.
501 SE Columbia Shores Blvd.
Suite 100
Vancouver,  WA  98661
Applicant Contact HERBERT J SEMLER
Correspondent
Semler Technologies, Inc.
501 SE Columbia Shores Blvd.
Suite 100
Vancouver,  WA  98661
Correspondent Contact HERBERT J SEMLER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received09/06/2000
Decision Date 09/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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