Cleared Traditional

DISCOGRAPHY KIT

K910503 · B. Braun of America, Inc. · Radiology
Oct 1991
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K910503 is an FDA 510(k) clearance for the DISCOGRAPHY KIT, a System, X-ray, Photofluorographic (Class II — Special Controls, product code IZG), submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on October 7, 1991, 244 days after receiving the submission on February 5, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1730.

Submission Details

510(k) Number K910503 FDA.gov
FDA Decision Cleared SESK
Date Received February 05, 1991
Decision Date October 07, 1991
Days to Decision 244 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code IZG — System, X-ray, Photofluorographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1730

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