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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 K970378
Device Name STRYKER 2115 REPLACEMENT BATTERY (2115)
Applicant
Implant Resource, Inc.
11975 Portland Ave. S.
Suite 138
Minneapolis,  MN  55337
Applicant Contact MICHAEL HOLLOWAY
Correspondent
Implant Resource, Inc.
11975 Portland Ave. S.
Suite 138
Minneapolis,  MN  55337
Correspondent Contact MICHAEL HOLLOWAY
Regulation Number878.4820
Classification Product Code
KIJ  
Date Received01/31/1997
Decision Date 04/30/1997
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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