Device Classification Name |
Kit, Nephroscope
|
510(k) Number |
K791182 |
Device Name |
ACMI RIGI-FLEX NEPHORSCOPE |
Applicant |
AMERICAN CYSTOCOPE MAKERS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
AMERICAN CYSTOCOPE MAKERS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/25/1979 |
Decision Date | 07/30/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|