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510(k) K983220

STRYKER INFRAVISION ESOPHAGEAL KIT by Stryker Endoscopy — Product Code FAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1999
Date Received
September 14, 1998
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

  • K133439 — PILLING ESOPHAGEAL BOUGIES (June 16, 2014)
  • 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)