BDH BIPOLAR FEMORAL COMPONENT A3

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

CARBOMEDICS, INC.

The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Bdh Bipolar Femoral Component A3.

Pre-market Notification Details

Device IDK833404
510k NumberK833404
Device Name:BDH BIPOLAR FEMORAL COMPONENT A3
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant CARBOMEDICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-30
Decision Date1984-03-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00889024169807 K833404 000
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00889024169890 K833404 000
00889024169883 K833404 000
00889024169876 K833404 000
00889024169869 K833404 000
00889024169746 K833404 000

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