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510(k) K010821

ECHOSEED/IODINE-125 SEEDS, MODEL 6733 by Medi-Physics Inc. Dba Nycomed Amersham Imaging — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2001
Date Received
March 19, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Medi-Physics Inc. Dba Nycomed Amersham Imaging

  • K940632 — I-125 RAPID STRAND (September 2, 1994)
  • K921961 — SDMO APPLICATOR CODE: ASN.8236 (July 1, 1992)
  • K915156 — I-125 SEEDS CODE: 6702 (January 6, 1992)
  • K914268 — I-125 SEEDS IN CARRIER, CODE: 6720 (November 22, 1991)
  • K914281 — I-125 SEEDS, CODE: 6711 (November 22, 1991)
  • K811677 — KRYPTON CART (July 2, 1981)
  • K811688 — TUNGSTEN SYRINGE SHIELD (July 2, 1981)
  • K811118 — KRYPTON MASKS & TUBING (June 2, 1981)

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