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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Extracorporeal Shock-Wave, Urological
510(k) Number K002801
Device Name MPS M ELECTRODE
Applicant
Medical Physics and Services, Inc.
1091 Irma Dr., Unit C
Denver,  CO  80233
Applicant Contact HOWARD C THOMAS
Correspondent
Medical Physics and Services, Inc.
1091 Irma Dr., Unit C
Denver,  CO  80233
Correspondent Contact HOWARD C THOMAS
Regulation Number876.5990
Classification Product Code
LNS  
Date Received09/08/2000
Decision Date 05/04/2001
Decision SE - With Limitations (SESU)
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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