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510(k) K863281

CARE + PLUS IRREGATION TRAY by Welmed Systems, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1986
Date Received
August 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Welmed Systems, Inc.

  • K863282 — CARE + PLUS CATHETER CARE TRAY (October 31, 1986)
  • K863497 — SUCTION CATHETER KIT (October 6, 1986)
  • K863284 — I.V. START KIT (September 22, 1986)
  • K863283 — CARE + PLUS SUTURE REMOVAL TRAY (September 15, 1986)
  • K862663 — TRACHEOSTOMY CARE TRAY (July 30, 1986)
  • K862219 — T.P.N. DRESSING CHANGE TRAY (July 8, 1986)

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