Home / 510(k) Clearances / K903342

510(k) K903342

DEODORIZING AND SOUND MUFFLING ANAL PAD by Biological Resistance, Inc. — Product Code EYQ

K903342 is an FDA 510(k) premarket notification submitted by Biological Resistance, Inc. for the device "DEODORIZING AND SOUND MUFFLING ANAL PAD". The FDA issued a decision of Substantially Equivalent on October 23, 1990. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1990
Date Received
July 25, 1990
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 for product code EYQ

  • K950784 — DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM (May 3, 1995)
  • K932310 — KIT PAK INCONTINENT SKIN CARE KIT (June 1, 1994)
  • 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