Device Classification Name |
catheter, irrigation
|
510(k) Number |
K895757 |
Device Name |
IRRI-EVACUATOR |
Applicant |
MIKRO-TEK LABORATORIES |
220 SOUTH LORI LN. |
BLOOMINGTON,
IN
47401
|
|
Applicant Contact |
THOMAS P CLEMENT |
Correspondent |
MIKRO-TEK LABORATORIES |
220 SOUTH LORI LN. |
BLOOMINGTON,
IN
47401
|
|
Correspondent Contact |
THOMAS P CLEMENT |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 09/26/1989 |
Decision Date | 10/19/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|