Home / 510(k) Clearances / K862380

510(k) K862380

MATTRESS COVER by Intera Corp. — Product Code EYQ

K862380 is an FDA 510(k) premarket notification submitted by Intera Corp. for the device "MATTRESS COVER". The FDA issued a decision of Substantially Equivalent on July 28, 1986. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Intera Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1986
Date Received
June 24, 1986
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)
  • K885185 — INTERA SHIELD AND INTERA UNDERGARMENT (February 8, 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)

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