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510(k) K830002

CAPD COLOR-GUARD SYSTEM PREPKIT by Abbott Laboratories — Product Code FKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1983
Date Received
January 3, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Tubing, Dialysate
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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Other clearances for product code FKY

  • K991003 — PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LO (June 9, 1999)
  • K862722 — TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE (August 11, 1986)
  • K771428 — TENCKHOFF PERITONEAL TUBING ADAPT. (October 18, 1977)