Device Classification Name |
Rod, Colostomy
|
510(k) Number |
K040110 |
Device Name |
EASY LOOP, MODEL EZL-01 |
Applicant |
TOOLS FOR SURGERY, LLC |
1339 STONY BROOK ROAD |
STONY BROOK,
NY
11790
|
|
Applicant Contact |
ARNOLD R LEIBOFF |
Correspondent |
TOOLS FOR SURGERY, LLC |
1339 STONY BROOK ROAD |
STONY BROOK,
NY
11790
|
|
Correspondent Contact |
ARNOLD R LEIBOFF |
Regulation Number | 876.4270
|
Classification Product Code |
|
Date Received | 01/20/2004 |
Decision Date | 03/24/2004 |
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
|
|
|