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510(k) K940550

COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH by Cook, Inc. — Product Code IWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1994
Date Received
February 7, 1994
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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Other clearances for product code IWJ

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  • K980997 — PGK DEVICE (MODIFIED) (September 28, 1998)
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  • K973037 — N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 (January 27, 1998)
  • K974118 — WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET (January 23, 1998)
  • K973786 — NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE (January 2, 1998)
  • K973638 — N.I.T., INC. NEEDLE GUIDING TEMPLATE (December 23, 1997)
  • K973184 — PROSTATE SEEDING NEEDLE (November 21, 1997)
  • K963743 — MANAN PROSTATE UNI-LOCK (December 6, 1996)
  • K951052 — WEEKS APPLICATOR (August 22, 1996)