Device Classification Name |
lithotriptor, electro-hydraulic
|
510(k) Number |
K822644 |
Device Name |
RIWOLITH 2135 |
Applicant |
R. WOLF MEDICAL INSTRUMENTS CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
R. WOLF MEDICAL INSTRUMENTS CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.4480
|
Classification Product Code |
|
Date Received | 09/01/1982 |
Decision Date | 09/21/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|