Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K172672 |
Device Name |
Endoscopic Applicator, 41 cm |
Applicant |
Micromedics Inc. (d/b/a Nordson Medical) |
1270 Eagan Industrial Road, Suite 120 |
St.Paul,
MN
55121
|
|
Applicant Contact |
Kristi Brezinka |
Correspondent |
Micromedics Inc. (d/b/a Nordson Medical) |
1270 Eagan Industrial Road, Suite 120 |
St.Paul,
MN
55121
|
|
Correspondent Contact |
Kristi Brezinka |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/05/2017 |
Decision Date | 10/06/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|