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510(k) K844186

CONTINENT STOMA SYSTEM & ACCESSORIES by Chesebrough-Pond'S U.S.A. Co. — Product Code KBG

K844186 is an FDA 510(k) premarket notification submitted by Chesebrough-Pond'S U.S.A. Co. for the device "CONTINENT STOMA SYSTEM & ACCESSORIES". The FDA issued a decision of Substantially Equivalent on January 15, 1985. The device falls under product code KBG (Trocar, Sinus), a Class I device regulated under 21 CFR 874.4420. Chesebrough-Pond'S U.S.A. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1985
Date Received
October 29, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar, Sinus
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Chesebrough-Pond'S U.S.A. Co.

  • K863866 — RESPIRADYNE II(TM) (January 28, 1987)
  • K862803 — CHESEBROUGH POND'S HYDROCOLLOID DRESSING (November 14, 1986)
  • K851382 — CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING (July 5, 1985)
  • K851383 — BLISTERFILM TRANSPARENT DRESSING (July 5, 1985)
  • K851539 — CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO (June 12, 1985)
  • K843567 — KANGAROO NASOGASTRIC FEEDING TUBE (February 14, 1985)
  • K845010 — CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH (January 15, 1985)
  • K843128 — FEMALE URINARY INCONTINENCE SYS (January 2, 1985)
  • K844789 — KANGAROO ACCESS II ENTERAL FEEDING CONTAINER (January 2, 1985)
  • K843139 — ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND (November 8, 1984)

Other clearances for product code KBG

  • K033591 — REPROCESSED TROCARS (June 3, 2005)
  • K013987 — REPROCESSED DISPOSABLE TROCARS (March 1, 2002)

FDA data resources