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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K051610
Device Name HANS HERMANN LAPAROSCOPES AND ACCESSORIES
Applicant
Hans Hermann GmbH
Unterer Winkel 3
Wurmlingen,  DE D-78567
Applicant Contact HARALD JUNG
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact STEFAN PREISS
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
GEI  
Date Received06/17/2005
Decision Date 07/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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