ROTAX-II BI-PLANE CIRCULAR ARM

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

B C MEDICAL LTD.

The following data is part of a premarket notification filed by B C Medical Ltd. with the FDA for Rotax-ii Bi-plane Circular Arm.

Pre-market Notification Details

Device IDK870205
510k NumberK870205
Device Name:ROTAX-II BI-PLANE CIRCULAR ARM
Classification510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
Applicant B C MEDICAL LTD. 1303 DE MAISONNEUVE BLVD. EAST MONTREAL, P.Q. Canada,  CA H2l 2a4
ContactPierre Charrier
CorrespondentPierre Charrier
B C MEDICAL LTD. 1303 DE MAISONNEUVE BLVD. EAST MONTREAL, P.Q. Canada,  CA H2l 2a4
Product Code510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood &
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-20
Decision Date1987-03-06

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