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510(k) K945204

URINE COLLECTOR & ACCESSORIES by Nelmed Corp. — Product Code FAQ

K945204 is an FDA 510(k) premarket notification submitted by Nelmed Corp. for the device "URINE COLLECTOR & ACCESSORIES". The FDA issued a decision of Substantially Equivalent on November 2, 1994. The device falls under product code FAQ (Bag, Urine Collection, Leg, For External Use, Sterile), a Class I device regulated under 21 CFR 876.5250. Nelmed Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1994
Date Received
October 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Urine Collection, Leg, For External Use, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Nelmed Corp.

  • K934772 — GASTRONOMY TUBE HOLDER (February 28, 1994)

Other clearances for product code FAQ

  • K962604 — PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZ (July 18, 1996)
  • K960217 — CPR URINE BAG (March 28, 1996)
  • K955609 — CONVEEN URINE BAG - STERILE (December 29, 1995)
  • K953767 — PROSYS BEDSIDE DRAINAGE BAG (December 20, 1995)
  • K953783 — CONVEEN LEG BAG STRAP (September 13, 1995)
  • K951945 — PROSYS LEG BAG (May 25, 1995)
  • K934052 — ALPINE REUSABLE LEG BAGS (January 7, 1994)
  • K931727 — URINARY DRAINAGE BAG CADDY (July 23, 1993)
  • K926035 — BARD LEG BAG HOLDER (December 17, 1992)
  • K924406 — CONVEEN(R) LEG BAG(500 ML) (October 30, 1992)

FDA data resources