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 DRIVE |
SAN DIEGO,
CA
92122
|
|
Applicant Contact |
FOSTER BOOP |
Correspondent |
THE LARYNGEAL MASK CO.,LTD. |
4660 LA JOLLA VILLAGE DRIVE |
SAN DIEGO,
CA
92122
|
|
Correspondent Contact |
FOSTER BOOP |
Regulation Number | 876.4480
|
Classification Product Code |
|
Date Received | 08/24/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|