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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K842759
Device Name MODEL 503FB
Applicant
Atrix
1210 SE 7th.
Portland,  OR  97214
Applicant Contact KIM F DUNCAN
Correspondent
Atrix
1210 SE 7th.
Portland,  OR  97214
Correspondent Contact KIM F DUNCAN
Classification Product Code
LOS
Date Received07/16/1984
Decision Date 01/18/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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