Cleared Traditional

K980997 - PGK DEVICE (MODIFIED)
(FDA 510(k) Clearance)

K980997 · Pgk, Inc. · Radiology
Sep 1998
Decision
195d
Days
Class 1
Risk

K980997 is an FDA 510(k) clearance for the PGK DEVICE (MODIFIED), a System, Applicator, Radionuclide, Manual (Class I — General Controls, product code IWJ), submitted by Pgk, Inc. (Vienna, US). The FDA issued a Cleared decision on September 28, 1998, 195 days after receiving the submission on March 17, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5650.

Submission Details

510(k) Number K980997 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1998
Decision Date September 28, 1998
Days to Decision 195 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IWJ — System, Applicator, Radionuclide, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.5650

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