Cleared Traditional

PENSIL TRAUMA, MODEL WWS6100

K993962 · Wuestec Medical, Inc. · Radiology
Dec 1999
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K993962 is an FDA 510(k) clearance for the PENSIL TRAUMA, MODEL WWS6100, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Wuestec Medical, Inc. (Mobile, US). The FDA issued a Cleared decision on December 21, 1999, 57 days after receiving the submission on October 25, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K993962 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1999
Decision Date December 21, 1999
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code KPR — System, X-ray, Stationary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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