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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Ultrasonic
510(k) Number K843101
Device Name KARL STORZ 27086KC ULTRASONIC LITHOTRI
Applicant
KARL STORZ Endoscopy-America, Inc.
10111 W. Jefferson Blvd.
Culver City,  CA  90232
Applicant Contact NORMAN SILBERTRUST
Correspondent
KARL STORZ Endoscopy-America, Inc.
10111 W. Jefferson Blvd.
Culver City,  CA  90232
Correspondent Contact NORMAN SILBERTRUST
Regulation Number876.4480
Classification Product Code
FEO  
Date Received08/07/1984
Decision Date 12/11/1984
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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