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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 K950492
Device Name ATRAUMAX SURGICAL CLAMP
Applicant
Applied Medical Resources
26051 Merit Circle
Bldg. 104
Launa Hills,  CA  92653
Applicant Contact HOWARD V ROWE
Correspondent
Applied Medical Resources
26051 Merit Circle
Bldg. 104
Launa Hills,  CA  92653
Correspondent Contact HOWARD V ROWE
Regulation Number870.4450
Classification Product Code
DXC  
Date Received02/06/1995
Decision Date 05/08/1995
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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