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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Fiberoptic
510(k) Number K080367
Device Name ZIMMER MIS LIGHT
Applicant
Zimmer Spine, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Applicant Contact ELSA A LINKE
Correspondent
Zimmer Spine, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Correspondent Contact ELSA A LINKE
Regulation Number878.4580
Classification Product Code
FST  
Date Received02/12/2008
Decision Date 02/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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