Device Classification Name |
lithotriptor, ultrasonic
|
510(k) Number |
K181364 |
Device Name |
Swiss LithoClast Trilogy |
Applicant |
EMS Electro Medical Systems SA |
Ch dela Vuarpilliere |
Nyon,
CH
1260
|
|
Applicant Contact |
Sonia Callegaro |
Correspondent |
Heyer Regulatory Solutions LLC |
125 Cherry Lane |
Amherst,
MA
01002
|
|
Correspondent Contact |
Sheila Hemeon-Heyer |
Regulation Number | 876.4480
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/23/2018 |
Decision Date | 06/20/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|