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510(k) K971911

LUMAX CYSTOMETRY ADMINISTRATION TUBE SET by Medamicus, Inc. — Product Code FEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1997
Date Received
April 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Cystometric, Hydraulic
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

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  • K994097 — MEDAMICUS EPIDURAL INTRODUCER (March 1, 2000)
  • K990705 — MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR S (June 28, 1999)

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