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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 K062475
Device Name LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM
Applicant
The Laryngeal Mask Co., Ltd.
4660 La Jolla Village Dr.
San Diego,  CA  92122
Applicant Contact FOSTER BOOP
Correspondent
The Laryngeal Mask Co., Ltd.
4660 La Jolla Village Dr.
San Diego,  CA  92122
Correspondent Contact FOSTER BOOP
Regulation Number876.4480
Classification Product Code
FFK  
Date Received08/24/2006
Decision Date 05/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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