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510(k) K843481

PHARMA-PLAST CONNECTING TUBE TYPE URIN- by Zimmar Consulting , Ltd. — Product Code KNX

K843481 is an FDA 510(k) premarket notification submitted by Zimmar Consulting , Ltd. for the device "PHARMA-PLAST CONNECTING TUBE TYPE URIN-". The FDA issued a decision of Substantially Equivalent on October 18, 1984. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Zimmar Consulting , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1984
Date Received
September 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Zimmar Consulting , Ltd.

  • K860322 — CLINISET INFUSION SET (April 7, 1986)
  • K843477 — PHARMA-PLAST RECTAL TIP (December 5, 1984)
  • K843478 — PHARMA-PLAST URIDROP-URIDOME (December 5, 1984)
  • K843468 — PHARMA-PLAST SUCTION SET TYPE YANKAUER (November 23, 1984)
  • K843466 — PHARMA-PLAST OXYGEN CATHETER (November 19, 1984)
  • K843467 — PHARMA-PLAST NASAL OXYGEN CANNULA (November 19, 1984)
  • K843469 — PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE- (November 19, 1984)
  • K843470 — PHARMA-PLAST CONNECTING TUBE TYPE SUCT- (November 16, 1984)
  • K843472 — PHARMA-PLAST SYRINGE WITH NEEDLE (October 31, 1984)
  • K843473 — PHARMA-PLAST INSULIN SYRINGE (October 31, 1984)

Other clearances for product code KNX

  • K110518 — IBAG (June 24, 2011)
  • K973364 — 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG (March 17, 1998)
  • K972887 — MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG (December 11, 1997)
  • K971271 — BESECURE EXTERNAL URINARY COLLECTION SYSTEM (August 18, 1997)
  • K971929 — AMSINO URINARY LEG BAG (August 6, 1997)
  • K971764 — WELCON HUE-VU URINARY DRAINAGE BAG (July 29, 1997)
  • K964690 — LIBERTY VALVE (March 21, 1997)
  • K964745 — AMSINO URINARY DRAINAGE BAG (March 18, 1997)
  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
  • K960949 — PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (April 19, 1996)

FDA data resources