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510(k) K884379

MAGLINTE ENTEROCLYSIS CATHETER by Lafayette Pharmacal, Inc. — Product Code FGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1989
Date Received
October 18, 1988
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 Lafayette Pharmacal, Inc.

  • K931896 — PRO-FLO SYSTEM (August 26, 1993)
  • K881609 — SITZMARKS (July 8, 1988)
  • K860441 — ENTROKIT WITH MAGLINTE CATHETER (March 12, 1986)

Other clearances for product code FGD

  • K223890 — NAJA Gastrointestinal Catheter (June 16, 2023)
  • K905026 — DUAL FLEX NON-LATEX (December 18, 1991)
  • K905574 — SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF (January 24, 1991)
  • K904299 — SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF (November 27, 1990)
  • K872006 — DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF (November 17, 1987)