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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
510(k) Number K951450
Device Name SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY
Applicant
Strenumed, Inc.
316 Pomo St.
Ventura,  CA  93001
Applicant Contact DOUGLAS WALKER
Correspondent
Strenumed, Inc.
316 Pomo St.
Ventura,  CA  93001
Correspondent Contact DOUGLAS WALKER
Regulation Number878.4820
Classification Product Code
KIJ  
Date Received03/29/1995
Decision Date 05/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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