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510(k) K970465

BOUSER'S URINAL by General Polymers — Product Code EXJ

K970465 is an FDA 510(k) premarket notification submitted by General Polymers for the device "BOUSER'S URINAL". The FDA issued a decision of Substantially Equivalent on December 18, 1997. The device falls under product code EXJ (Device, Incontinence, Urosheath Type, Sterile), a Class I device regulated under 21 CFR 876.5250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1997
Date Received
February 7, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Incontinence, Urosheath Type, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances for product code EXJ

  • K972100 — VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) (July 31, 1997)
  • K970966 — COMFORT CATH CHOICE MALE EXTERNAL CATHETER (April 22, 1997)
  • K963265 — PROSYS SAMEC LA (October 25, 1996)
  • K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETER (September 16, 1996)
  • K962413 — COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER (July 15, 1996)
  • K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER (July 15, 1996)
  • K952082 — ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER (July 18, 1995)
  • K945628 — CLEAR ADVANTAGE II (July 6, 1995)
  • K951530 — PROSYS URIHESIVE SYSTEM LA (May 12, 1995)
  • K950690 — PROSYS URIHESICE SYSTEM NL (March 23, 1995)

FDA data resources