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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K040727
Device Name CRYO 5
Applicant
Zimmer Elektromedizin GmbH
Junkersstrasse 9
Neu-Ulm,  DE D-89231
Applicant Contact STEFAN LEINWEBER
Correspondent
Tuv America, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/22/2004
Decision Date 04/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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