Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K122526 |
Device Name |
360 GAS ASSISTED ENDOSCOPIC APPLICATOR |
Applicant |
MICROMEDICS, INC. |
1270 Eagan Industrial Rd Ste 120 |
Saint Paul,
MN
55121
|
|
Applicant Contact |
JODI L RAUS |
Correspondent |
MICROMEDICS, INC. |
1270 Eagan Industrial Rd Ste 120 |
Saint Paul,
MN
55121
|
|
Correspondent Contact |
JODI L RAUS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/20/2012 |
Decision Date | 11/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|