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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 K933600
Device Name NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS
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 Received07/27/1993
Decision Date 03/28/1994
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
Predetermined Change
Control Plan Authorized		 No
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