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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lithotriptor, electro-hydraulic
510(k) Number K830086
Device Name 4.5 F LITHOTRIPTOR ELECTRODE
Applicant
MONAGHAN MEDICAL CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MONAGHAN MEDICAL CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.4480
Classification Product Code
FFK  
Date Received01/11/1983
Decision Date 02/09/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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