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510(k) K885185

INTERA SHIELD AND INTERA UNDERGARMENT by Intera Corp. — Product Code EYQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1989
Date Received
December 14, 1988
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 Intera Corp.

  • K891686 — LIB SYSTEM, BABY/ADULT DIAPER (May 31, 1989)
  • K883787 — REUSABLE ADULT INCONTINENT DIAPER (November 7, 1988)
  • K883424 — SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB (September 6, 1988)
  • K863732 — SURGICAL DRAPE & DRAPE ACCESSORIES (October 23, 1986)
  • K862380 — MATTRESS COVER (July 28, 1986)

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)
  • 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)