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510(k) K950784

DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM by Advanced Bioresearch Assoc. — Product Code EYQ

K950784 is an FDA 510(k) premarket notification submitted by Advanced Bioresearch Assoc. for the device "DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on May 3, 1995. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Advanced Bioresearch Assoc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1995
Date Received
February 21, 1995
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 Advanced Bioresearch Assoc.

  • K943695 — SURETEMP (April 21, 1995)
  • K944619 — I.V.I.D. FLUID ADMINISTRATION SET MARKER (January 26, 1995)

Other clearances for product code EYQ

  • 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)
  • K880455 — AT EASE ADULT DIAPER (April 14, 1988)

FDA data resources