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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K870205
Device Name ROTAX-II BI-PLANE CIRCULAR ARM
Applicant
B C Medical , Ltd.
1303 De Maisonneuve Blvd. E.
Montreal, P.Q.
Canada,  CA H2L 2A4
Applicant Contact PIERRE CHARRIER
Correspondent
B C Medical , Ltd.
1303 De Maisonneuve Blvd. E.
Montreal, P.Q.
Canada,  CA H2L 2A4
Correspondent Contact PIERRE CHARRIER
Date Received01/20/1987
Decision Date 03/06/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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