PGK DEVICE (MODIFIED)— 510(k) K980997

Substantially Equivalent

Pgk, Inc.

FDA 510(k) clearance K980997 for PGK DEVICE (MODIFIED), Substantially Equivalent on 1998-09-28. Applicant: Pgk, Inc.. Device class: 1.

Clearance details

Applicant
Pgk, Inc.
Product code
Code IWJ
Device class
Class 1
Regulation
21 CFR 892.5650
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Vienna, VA, US
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