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510(k) K990935

JACKSON ESOPHAGEAL DILATOR by Pilling Weck Surgical — Product Code KNQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1999
Date Received
March 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Esophageal
Device Class
Class II
Regulation Number
876.5365
Review Panel
GU
Submission Type

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  • K990561 — OPTICAL FORCEPS (May 14, 1999)
  • K982128 — SHIKANI-FRENCH SPEAKING VALVE (October 23, 1998)

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  • K061937 — COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON (December 1, 2006)
  • K061787 — MAXFORCE TTS SINGLE-USE BALLOON DILATOR (September 21, 2006)
  • K060302 — INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED (April 11, 2006)
  • K043605 — INSCOPE 3-STAGE BALLOON DILATOR (February 4, 2005)
  • K033936 — BARD ELIMINATOR PET BALLOON DILATORS (January 14, 2004)
  • K031147 — OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR (January 12, 2004)