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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Irrigation, Urological
510(k) Number K940983
Device Name THE KARL STORZ UROMAT(TM)
Applicant
KARL STORZ Endoscopy-America, Inc.
1201 Roberts Blvd.
Kennesaw,  GA  30144
Applicant Contact PAUL L SUMNER
Correspondent
KARL STORZ Endoscopy-America, Inc.
1201 Roberts Blvd.
Kennesaw,  GA  30144
Correspondent Contact PAUL L SUMNER
Regulation Number876.5130
Classification Product Code
LJH  
Date Received03/01/1994
Decision Date 09/20/1994
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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