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510(k) K781930

PANT LINER, DISP. INCONTINENT by Fibre Formations, Inc. — Product Code EYQ

K781930 is an FDA 510(k) premarket notification submitted by Fibre Formations, Inc. for the device "PANT LINER, DISP. INCONTINENT". The FDA issued a decision of Substantially Equivalent on February 1, 1979. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Fibre Formations, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1979
Date Received
November 15, 1978
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 Fibre Formations, Inc.

  • K791709 — HEEL/ELBOW PROTECTORS (September 24, 1979)
  • K790922 — DISPOSABLE ADULT DIAPER (July 30, 1979)
  • K781233 — IV ARMBOARDS (August 14, 1978)
  • K781246 — FOAM COMFORT RINGS (August 10, 1978)

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