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510(k) K837465

ALCYON ROTATIONAL COBALT THERAPY by Cgr Medical Corp.

K837465 is an FDA 510(k) premarket notification submitted by Cgr Medical Corp. for the device "ALCYON ROTATIONAL COBALT THERAPY". The FDA issued a decision of Substantially Equivalent on June 28, 1983. Cgr Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1983
Date Received
May 3, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Cgr Medical Corp.

  • K843926 — PRESTILIX 1690 (December 17, 1984)
  • K843235 — STENOSCOP (November 8, 1984)
  • K843985 — SUSPENSION 7 (November 5, 1984)
  • K841649 — MAXIMAX - 4 (June 5, 1984)
  • K833223 — SONEL 3000A (May 9, 1984)
  • K833941 — ORION (December 29, 1983)
  • K834306 — PHASIX-HIGH FREQUENCY GENERATOR (December 29, 1983)
  • K833846 — PROCESS 100 ST (December 16, 1983)
  • K837412 — SATURNE I LINEAR ACCELERATOR (June 28, 1983)
  • K837336 — VERASUN RADIATION THERAPY SIMULATION SYSTEM (April 29, 1983)

FDA data resources