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510(k) K841953

ULTRA SHIELD BRIEFS by Ipco Corp. — Product Code EYQ

K841953 is an FDA 510(k) premarket notification submitted by Ipco Corp. for the device "ULTRA SHIELD BRIEFS". The FDA issued a decision of Substantially Equivalent on July 19, 1984. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Ipco Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1984
Date Received
May 14, 1984
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 Ipco Corp.

  • K871270 — PERFORM DENTURE BASE RESIN (May 29, 1987)
  • K850666 — STROBEX ULTRON ELECTROSURGE-DENTAL UNIT (May 29, 1985)
  • K850906 — TACTILE PLUS DENTAL ELEVATORS (April 12, 1985)
  • K842837 — SAFE & SOFT MAXI SHILEDS (October 15, 1984)
  • K842836 — SAFE & SOFT MINI PADS & MAXI PADS (October 15, 1984)
  • K842838 — SAFE & SOFT PANTY SHIELDS (October 5, 1984)
  • K840754 — MAXISHIELD INCONTINENCE CARE SYSTEM (April 13, 1984)
  • K840755 — MINIGARD DISPOSABLE LINERS (April 13, 1984)
  • K840753 — AMBEZE DISPOSABLE INCONTINENCE PANTS (April 13, 1984)
  • K800291 — ENDEX REAMERS PULP CANAL, ENDODONTIC (February 19, 1980)

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