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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Irrigation
510(k) Number K932391
Device Name NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET
Applicant
NAVARRE BIOMEDICAL LTD.
705 TOWER DR.
HAMEL,  MN  55340
Applicant Contact GREGG S SUTTON
Correspondent
NAVARRE BIOMEDICAL LTD.
705 TOWER DR.
HAMEL,  MN  55340
Correspondent Contact GREGG S SUTTON
Regulation Number878.4200
Classification Product Code
GBX  
Date Received05/18/1993
Decision Date 01/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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