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510(k) K820435

BAXA ADDISEAL by Baxa Corp., Sub. of Cook Group, Inc. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1982
Date Received
February 17, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

Other clearances by Baxa Corp., Sub. of Cook Group, Inc.

  • K910257 — BAXA PCA INFUSOR (November 7, 1991)
  • K903159 — VALVE CONTROLLER FOR MICROMACRO COMPOUNDER (November 7, 1990)
  • K904225 — KWIKMIX (November 5, 1990)
  • K900585 — TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP (April 18, 1990)
  • K873875 — BAXA EXACTA-MED PHARMACY PUMP (November 24, 1987)
  • K872743 — BAXA TUBING SETS (FOR PHARMACY PUMP) (October 9, 1987)
  • K844904 — CYTOSAFE NEEDLE (February 22, 1985)
  • K832347 — TWOFER NEEDLE (September 12, 1983)
  • K832312 — I.V. TRANSFER NEEDLE (September 12, 1983)
  • K832332 — VENTED I.V. TRANSFER NEEDLE (September 12, 1983)

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