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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 K021456
Device Name ER150/M2
Applicant
World of Medicine Lemke GmbH
91 Trowbridge St.
Cambridge,  MA  02138
Applicant Contact SUSANNE RAAB
Correspondent
World of Medicine Lemke GmbH
91 Trowbridge St.
Cambridge,  MA  02138
Correspondent Contact SUSANNE RAAB
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/06/2002
Decision Date 08/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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