510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870205Substantially Equivalent

Rotax-II Bi-Plane Circular Arm

B C Medical, Ltd., Canada, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870205 is the FDA 510(k) clearance record for ROTAX-II BI-PLANE CIRCULAR ARM, cleared for B C Medical , Ltd. on . FDA records list 8 510(k) clearances for B C Medical , Ltd., from to . As of , FDA records show no recalls naming K870205.

Clearance record

Decision date
Received
(45 days to decision)
Review panel
Unknown
Applicant
B C Medical , Ltd. 1303 De Maisonneuve Blvd. E., Canada, CA
Third party review
No