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510(k) K822535

CIDEX*DIALYZER DISINFECTING SOLUTION by Surgikos, Inc. — Product Code FKQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1982
Date Received
August 24, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Central Multiple Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Surgikos, Inc.

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  • K874653 — STERILE SURGICAL SCRUB BRUSH (December 30, 1987)
  • K861441 — NEUTRALON SURGICAL GLOVES (May 30, 1986)
  • K852870 — BARRIER SURGICAL GOWN (July 23, 1985)
  • K820543 — BARRIER ANTIMICROBIAL INCISE DRAPE (July 22, 1982)
  • K820542 — SURGIKOS INCISE DRAPE (June 2, 1982)
  • K811871 — BACTERICIDAL INCISE DRAPE (August 20, 1981)
  • K810316 — SURGIKOS FACE MASK (February 23, 1981)
  • K801864 — BARRIER APERTURED DRAPE (August 20, 1980)
  • K801863 — BARRIER TOWEL DRAPE (August 20, 1980)

Other clearances for product code FKQ

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  • K893612 — TWO TANK DISSOLUTION MODULE (July 24, 1989)
  • K874084 — MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM (April 27, 1988)
  • K873421 — KAWASUMI A.V. FISTULA SET (October 9, 1987)
  • K870889 — ACID FUCHSIN SOLUTIONS (July 8, 1987)
  • K861730 — ACTRIL FOR KIDNEY MACHINE DISINFECTANT (June 9, 1987)
  • K864635 — FOUR TANK DISSOLUTION MODULE (January 13, 1987)
  • K862304 — DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM (September 9, 1986)
  • K861472 — MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 (July 10, 1986)
  • K852359 — AMUCHINA/DIALYZER DISINFECTANT (May 13, 1986)