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510(k) K820961

INCONTINENCE PAD OR ADULT DIAPER by Dafoe & Dafoe, Inc. — Product Code EYQ

K820961 is an FDA 510(k) premarket notification submitted by Dafoe & Dafoe, Inc. for the device "INCONTINENCE PAD OR ADULT DIAPER". The FDA issued a decision of Substantially Equivalent on April 16, 1982. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Dafoe & Dafoe, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1982
Date Received
April 6, 1982
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 Dafoe & Dafoe, Inc.

  • K820960 — MAXI & MINI SHIELDS (May 14, 1982)
  • K820962 — COTTON SWABS (April 20, 1982)
  • K800747 — BELTLESS MAXI, MINI & SUPER MAXI PADS (April 29, 1980)

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