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510(k) K810249

TRAY, CATHERIZATION, URETHRAL by Megaplast, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1981
Date Received
January 29, 1981
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 Megaplast, Inc.

  • K822158 — OPEN HEART TRAY (CUSTOM DESIGNED) (October 13, 1982)
  • K821313 — SURGICAL UTILITY DRAPE (June 21, 1982)
  • K820423 — SUTURE REMOVAL TRAY (March 10, 1982)
  • K820136 — URINARY DRAINAGE BAG (January 29, 1982)
  • K810250 — TRAY, IRRIGATION (April 7, 1981)
  • K810251 — SYRINGE, ENT (March 11, 1981)

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  • K181144 — Angled Tip Ureteral Catheter (June 28, 2018)
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