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510(k) K813487

CATHETER BUBBLE STAND by Accurate Surgical Instruments Co. — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Accurate Surgical Instruments Co.

  • K950042 — SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER (December 15, 1995)
  • K920515 — INSERTION (May 4, 1992)
  • K910786 — TROCAR (FALLER STYLET) (September 19, 1991)
  • K910785 — TITANIUM CATHETER EXTENDER (August 22, 1991)
  • K910787 — TITANIUM CONNECTOR (2 PART) (August 15, 1991)
  • K862046 — SWAN-NECK PERITONEAL DIALYSIS CATHETERS (June 19, 1986)
  • K850214 — STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN (July 26, 1985)
  • K813488 — CATHETER REGULAR (December 31, 1981)

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