Device Classification Name |
kit, nephroscope
|
510(k) Number |
K072594 |
Device Name |
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM |
Applicant |
GYRUS ACMI, INC. |
136 TURNPIKE RD. |
SOUTHBOROUGH,
MA
01772
|
|
Applicant Contact |
GRAHAM A BAILLIE |
Correspondent |
GYRUS ACMI, INC. |
136 TURNPIKE RD. |
SOUTHBOROUGH,
MA
01772
|
|
Correspondent Contact |
GRAHAM A BAILLIE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/14/2007 |
Decision Date | 12/13/2007 |
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
|
|
|