Device Classification Name |
Pneumoperitoneum Needle
|
510(k) Number |
K951894 |
Device Name |
ACCESS EXPANSION SYSTEM |
Applicant |
MICRO-MEDICAL DEVICES, INC. |
317 PARAGON WAY |
CASTLE ROCK,
CO
80104
|
|
Applicant Contact |
EDWIN L ADAIR |
Correspondent |
MICRO-MEDICAL DEVICES, INC. |
317 PARAGON WAY |
CASTLE ROCK,
CO
80104
|
|
Correspondent Contact |
EDWIN L ADAIR |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/24/1995 |
Decision Date | 06/15/1995 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|