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510(k) K041983

OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 by Opticon Medical — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2004
Date Received
July 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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  • K904999 — WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE (January 26, 1993)
  • K895955 — LOPER CELIAC PLEXUS BLOCK CATHETER KIT (February 22, 1990)
  • K895476 — OPTION EPIDURAL CATHETERS (January 19, 1990)

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