Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K162059 |
Device Name |
EZEE RETRIEVAL |
Applicant |
GENICON, INC |
6869 STAPOINT COURT |
SUITE 114 |
WINTER PARK,
FL
32792
|
|
Applicant Contact |
KATLYN KACHMAN |
Correspondent |
GENICON, INC |
6869 STAPOINT COURT |
SUITE 114 |
WINTER PARK,
FL
32792
|
|
Correspondent Contact |
KATLYN KACHMAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/26/2016 |
Decision Date | 09/29/2016 |
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
|
Recalls |
CDRH Recalls
|
|
|