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510(k) K002363

MEDOVATIONS ESOPHAGEAL DILATOR by Medovations, Inc. — Product Code KNQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2000
Date Received
August 3, 2000
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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  • K043605 — INSCOPE 3-STAGE BALLOON DILATOR (February 4, 2005)
  • K033936 — BARD ELIMINATOR PET BALLOON DILATORS (January 14, 2004)
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