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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Battery, Replacement, Rechargeable
510(k) Number K013133
Device Name NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
Applicant
Nordix, Inc.
6831 N. 21st Ave.
Phoenix,  AZ  85015
Applicant Contact MARIAN LISAK
Correspondent
Nordix, Inc.
6831 N. 21st Ave.
Phoenix,  AZ  85015
Correspondent Contact MARIAN LISAK
Regulation Number878.4820
Classification Product Code
MOQ  
Date Received09/19/2001
Decision Date 11/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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