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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K001736
Device Name GALEO HYDRO AND GALEO HYDRO J-TIP
Applicant
Biotronik, Inc.
6024 Jean Rd.
Lake Oswego,  OR  97035
Applicant Contact Jon Brumbaugh
Correspondent
Biotronik, Inc.
6024 Jean Rd.
Lake Oswego,  OR  97035
Correspondent Contact Jon Brumbaugh
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/07/2000
Decision Date 08/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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