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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Nephroscope
510(k) Number K940594
Device Name KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE
Applicant
KARL STORZ Endoscopy-America, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
KARL STORZ Endoscopy-America, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number876.1500
Classification Product Code
FGA  
Date Received02/09/1994
Decision Date 09/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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