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510(k) K133439

PILLING ESOPHAGEAL BOUGIES by Teleflexmedical, Inc. — Product Code FAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2014
Date Received
November 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Device Class
Class II
Regulation Number
876.5365
Review Panel
GU
Submission Type

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Other clearances for product code FAT

  • K983220 — STRYKER INFRAVISION ESOPHAGEAL KIT (June 4, 1999)
  • K972119 — MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) (February 2, 1998)
  • K960173 — INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT (June 27, 1996)
  • K901425 — PYLORIC BALLOON DILATOR (June 21, 1990)
  • K843186 — ESKA MULTISTAGE ESOPHAGEAL BOUGIE (January 18, 1985)
  • K842679 — ESOPHAGEAL DILATOR SET (October 2, 1984)
  • K780471 — GASTRIC LAVAGE KIT (June 2, 1978)