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510(k) K941447

SIMPLA S4, S5, S7 by Simpla Plastics , Ltd. — Product Code KNX

K941447 is an FDA 510(k) premarket notification submitted by Simpla Plastics , Ltd. for the device "SIMPLA S4, S5, S7". The FDA issued a decision of Substantially Equivalent on July 18, 1994. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1994
Date Received
March 24, 1994
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

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  • 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