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510(k) K834359

ABSORBENT INCONTINENT PADS & BRIEFS by Weyerhaeuser Co. — Product Code EYQ

K834359 is an FDA 510(k) premarket notification submitted by Weyerhaeuser Co. for the device "ABSORBENT INCONTINENT PADS & BRIEFS". The FDA issued a decision of Substantially Equivalent on March 5, 1984. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Weyerhaeuser Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1984
Date Received
December 13, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Garment, Protective, For Incontinence
Device Class
Class I
Regulation Number
876.5920
Review Panel
GU
Submission Type

Other clearances by Weyerhaeuser Co.

  • K883895 — DRIPRIDE ULTRA INCONTINENT PAD (January 30, 1989)
  • K883894 — DRIPRIDE PROVIDE SLIM (January 30, 1989)
  • K881859 — DRIPRIDE DISPOSABLE UNDERPAD (June 3, 1988)
  • K872059 — DRIPRIDE PROVIDE ULTRA (March 16, 1988)
  • K871725 — DRIPRIDE DISPOSABLE UNDERPADS (May 15, 1987)
  • K854408 — ADULT ABSORBENT INCONTINENT BRIEF (November 19, 1985)
  • K831593 — MAXI SHIELDS (August 12, 1983)
  • K830224 — UNSCENTED PANTY SHIELDS (February 8, 1983)
  • K812577 — UNSCENTED MENSTRUAL PADS (October 19, 1981)

Other clearances for product code EYQ

  • K950784 — DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM (May 3, 1995)
  • K932310 — KIT PAK INCONTINENT SKIN CARE KIT (June 1, 1994)
  • K903342 — DEODORIZING AND SOUND MUFFLING ANAL PAD (October 23, 1990)
  • K891686 — LIB SYSTEM, BABY/ADULT DIAPER (May 31, 1989)
  • K885185 — INTERA SHIELD AND INTERA UNDERGARMENT (February 8, 1989)
  • K883895 — DRIPRIDE ULTRA INCONTINENT PAD (January 30, 1989)
  • K883894 — DRIPRIDE PROVIDE SLIM (January 30, 1989)
  • K883787 — REUSABLE ADULT INCONTINENT DIAPER (November 7, 1988)
  • K882418 — DRY COMFORT UNDERGARMENT (September 29, 1988)
  • K880454 — AT EASE STRESS PAD (June 16, 1988)

FDA data resources