Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K132375 |
Device Name |
GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG |
Applicant |
GENICON |
6869 STAPOINT CT., SUITE 114 |
WINTER PARK,
FL
32792
|
|
Applicant Contact |
KATLYN TISSUE |
Correspondent |
GENICON |
6869 STAPOINT CT., SUITE 114 |
WINTER PARK,
FL
32792
|
|
Correspondent Contact |
KATLYN TISSUE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/30/2013 |
Decision Date | 06/12/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|