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510(k) K854729

ADAM (ABSORBENT INCONTINENCE SHIELD) by Lic-Orthion — Product Code EYQ

K854729 is an FDA 510(k) premarket notification submitted by Lic-Orthion for the device "ADAM (ABSORBENT INCONTINENCE SHIELD)". The FDA issued a decision of Substantially Equivalent on February 6, 1986. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Lic-Orthion has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1986
Date Received
November 25, 1985
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 Lic-Orthion

  • K891649 — PATIENT EXAMINATION GLOVES (LATEX) (April 4, 1989)
  • K862022 — LIC-ORTHION MULTI-THERAPY TREATMENT TABLE (June 19, 1986)
  • K854730 — DAISY (ABSORBENT INCONTINENCE SHIELD) (February 6, 1986)
  • K851470 — BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR (June 12, 1985)
  • K851471 — TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR (June 12, 1985)
  • K843234 — CITOMAT AUTOCLAVES (October 25, 1984)
  • K843233 — ANATOM SYSTEM (October 25, 1984)
  • K830853 — LAVATORY SEAT HEIGHTENER (June 8, 1983)
  • K830855 — SESAM TREATMENT TABLE (April 5, 1983)
  • K830851 — BATH TUB SEAT & BATH BOARD (April 5, 1983)

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