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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Miniature Pressure
510(k) Number K915326
Device Name PORTABLE LIMB LOAD MONITOR (BMLLM-100)
Applicant
Bar Med Pty , Ltd.
P.O. Box 1090
Collingwood, Victoria, 3066
Australia,  AU
Applicant Contact PETER BARRETT
Correspondent
Bar Med Pty , Ltd.
P.O. Box 1090
Collingwood, Victoria, 3066
Australia,  AU
Correspondent Contact PETER BARRETT
Regulation Number890.1615
Classification Product Code
IKE  
Date Received11/22/1991
Decision Date 10/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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