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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 K955505
Device Name OPTI-DRAIN MULTI-USE DRAINAGE CATHETER
Applicant
Navarre Biomedical , Ltd.
2545 Fernbrook Ln. N.
Plymouth,  MN  55447
Applicant Contact KELLY BEHRENDT
Correspondent
Navarre Biomedical , Ltd.
2545 Fernbrook Ln. N.
Plymouth,  MN  55447
Correspondent Contact KELLY BEHRENDT
Regulation Number878.4200
Classification Product Code
GBX  
Date Received12/01/1995
Decision Date 02/07/1996
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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