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510(k) K980997

PGK DEVICE (MODIFIED) by Pgk, Inc. — Product Code IWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1998
Date Received
March 17, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Manual
Device Class
Class I
Regulation Number
892.5650
Review Panel
RA
Submission Type

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  • K963743 — MANAN PROSTATE UNI-LOCK (December 6, 1996)
  • K951052 — WEEKS APPLICATOR (August 22, 1996)
  • K961377 — MANAN PROSTATE LOCKING INTRODUCER SET (July 3, 1996)