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510(k) K930556

NIGHT URINARY DRAINAGE BEDSIDE BAG by Ezmt Valve Co., Inc. — Product Code EYZ

K930556 is an FDA 510(k) premarket notification submitted by Ezmt Valve Co., Inc. for the device "NIGHT URINARY DRAINAGE BEDSIDE BAG". The FDA issued a decision of Substantially Equivalent on May 14, 1993. The device falls under product code EYZ (System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile), a Class I device regulated under 21 CFR 876.5250. Ezmt Valve Co., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1993
Date Received
February 3, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Ezmt Valve Co., Inc.

  • K930557 — LATEX EXAMINATION GLOVE (September 23, 1993)
  • K913155 — LEG URINAL (September 16, 1991)

Other clearances for product code EYZ

  • K964219 — ZIP CONDOM CATHETER (August 11, 1997)
  • K961906 — UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10 (November 19, 1996)
  • K952780 — URINARY GEL DRAINAGE SYSTEM (December 12, 1995)
  • K951597 — URINARY DRAINAGE BAG (August 4, 1995)
  • K942753 — ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER (November 2, 1994)
  • K933126 — COMFORTCARE SYSTEM (February 25, 1994)
  • K896695 — DYNA-FLO URINARY DRAINAGE BAG (May 2, 1990)
  • K901000 — URO TEX URINALS (March 26, 1990)
  • K890465 — CLOSED SYSTEM URINARY DRAINAGE BAG (May 23, 1989)
  • K891178 — TECNOL SECURE-ALL TUBE HOLDER (May 23, 1989)

FDA data resources