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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 K951475
Device Name NAVARRE UNIVERSAL DRAINAGE CATHETER
Applicant
NAVARRE BIOMEDICAL LTD.
2545 FERNBROOK LN. NORTH
PLYMOUTH,  MN  55447
Applicant Contact GREGG S SUTTON
Correspondent
NAVARRE BIOMEDICAL LTD.
2545 FERNBROOK LN. NORTH
PLYMOUTH,  MN  55447
Correspondent Contact GREGG S SUTTON
Regulation Number878.4200
Classification Product Code
GBX  
Date Received03/30/1995
Decision Date 04/24/1995
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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