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510(k) K872006

DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF by Mac Lee Medical Products — Product Code FGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1987
Date Received
May 26, 1987
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 Mac Lee Medical Products

  • K872953 — DISPOSABLE I.V. ADMINISTRATION SET (January 6, 1988)
  • K870995 — SCALP VEIN SET (July 31, 1987)
  • K864779 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC (December 29, 1986)
  • K864778 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC (December 29, 1986)
  • K864781 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC (December 29, 1986)
  • K864777 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC (December 29, 1986)
  • K864782 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC (December 23, 1986)
  • K864780 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC (December 23, 1986)
  • K864783 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC (December 23, 1986)
  • K841710 — MAC LEE VAGINAL IRRIGATOR (June 19, 1984)

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)
  • K884379 — MAGLINTE ENTEROCLYSIS CATHETER (February 28, 1989)