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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K841235
Device Name MEDO MEDOMER MBF-100 II
Applicant
Medo U.S.A., Inc.
P.O. Box 129
Wood Dale,  IL  60191
Applicant Contact HIROSHI OKAZAKI
Correspondent
Medo U.S.A., Inc.
P.O. Box 129
Wood Dale,  IL  60191
Correspondent Contact HIROSHI OKAZAKI
Regulation Number870.5800
Classification Product Code
JOW  
Date Received03/22/1984
Decision Date 11/19/1984
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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