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510(k) K955505

OPTI-DRAIN MULTI-USE DRAINAGE CATHETER by Navarre Biomedical , Ltd. — Product Code GBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1996
Date Received
December 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Navarre Biomedical , Ltd.

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  • K951907 — NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER (May 15, 1995)
  • K951475 — NAVARRE UNIVERSAL DRAINAGE CATHETER (April 24, 1995)
  • K943663 — NAVARRE 600 ML DRAINAGE BAG (September 8, 1994)
  • K942315 — NAVARRE PERCUTANEOUS ACCESS SET (July 8, 1994)
  • K933600 — NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS (March 28, 1994)
  • K932391 — NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET (January 27, 1994)

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  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
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