Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K042834 |
Device Name |
MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR |
Applicant |
MICROMEDICS, INC. |
1270 EAGAN INDUSTRIAL ROAD |
SUITE 120 |
ST PAUL,
MN
55121
|
|
Applicant Contact |
THOMAS A LOPAC |
Correspondent |
MICROMEDICS, INC. |
1270 EAGAN INDUSTRIAL ROAD |
SUITE 120 |
ST PAUL,
MN
55121
|
|
Correspondent Contact |
THOMAS A LOPAC |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/13/2004 |
Decision Date | 02/11/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|