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510(k) K800505

URETHRAL CATHETER by Medi-Craft , Ltd. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1980
Date Received
March 4, 1980
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 Medi-Craft , Ltd.

  • K861949 — SUCTION CATHETER KIT (October 22, 1986)
  • K800510 — RECTAL & HARRIS FLUSH TUBES (April 8, 1980)
  • K800508 — STOMACH TUBES (April 8, 1980)
  • K800507 — FEEDING TUBES (April 8, 1980)
  • K800506 — OXYGEN CATHETER (March 25, 1980)
  • K800509 — CONNECTING TUBES (March 25, 1980)
  • K800503 — SUCTION CATHETER (March 18, 1980)
  • K800504 — OXYGEN CONNECTING TUBES (March 18, 1980)

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