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510(k) K905026

DUAL FLEX NON-LATEX by Mmi, Inc. — Product Code FGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1991
Date Received
November 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention, Barium Enema With Bag
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Mmi, Inc.

  • K860445 — CLAMP-N-CUT (April 4, 1986)
  • K842130 — G.I. CLEANSING KIT (August 8, 1984)

Other clearances for product code FGD

  • K223890 — NAJA Gastrointestinal Catheter (June 16, 2023)
  • K905574 — SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF (January 24, 1991)
  • K904299 — SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF (November 27, 1990)
  • K884379 — MAGLINTE ENTEROCLYSIS CATHETER (February 28, 1989)
  • K872006 — DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF (November 17, 1987)