Device Classification Name |
Lithotriptor, Electro-Hydraulic
|
510(k) Number |
K895178 |
Device Name |
TECHNOMED PULSOLITH LASER SYSTEM |
Applicant |
TEKNOMED, INC. |
NORTH WOODS BUSINESS PARK |
99 ROSEWOOD DRIVE, SUITE 140 |
DANVERS,
MA
01923
|
|
Applicant Contact |
RICHARD HUNTER |
Correspondent |
TEKNOMED, INC. |
NORTH WOODS BUSINESS PARK |
99 ROSEWOOD DRIVE, SUITE 140 |
DANVERS,
MA
01923
|
|
Correspondent Contact |
RICHARD HUNTER |
Regulation Number | 876.4480 |
Classification Product Code |
|
Date Received | 08/10/1989 |
Decision Date | 10/06/1989 |
Decision |
Substantially Equivalent
(SESE) |
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
|
|
|