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510(k) K812311

CIRCULATING CYTO-THERMS by Cryosan, Inc. — Product Code KZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1981
Date Received
August 17, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Warming. Blood And Plasma
Device Class
Class II
Regulation Number
864.9205
Review Panel
HE
Submission Type

Other clearances by Cryosan, Inc.

  • K831953 — INFUSION PUMP (July 19, 1983)
  • K830831 — AUTOMATED BLOOD CELL SEPARATOR (June 16, 1983)
  • K822521 — AUTOMATED BLOOD CELL SEPARATOR (September 30, 1982)
  • K813489 — ROCKING/CIRCULATING CYTO-THERM II 3570 (March 4, 1982)
  • K812309 — CRYOSAN NORMAL SALINE (September 16, 1981)

Other clearances for product code KZL

  • K813489 — ROCKING/CIRCULATING CYTO-THERM II 3570 (March 4, 1982)
  • K800699 — FLO TEM (FLUID WARNER) (May 8, 1980)
  • K790936 — MODEL 114 TREONIC H150 HAEMOHEATER (September 4, 1979)