Device Classification Name |
endoscopic access overtube, gastroenterology-urology
|
510(k) Number |
K192691 |
Device Name |
PatCom Single-Use Introducer |
Applicant |
H&A Mui Enterprises Inc. |
145 Traders Blvd. E., Unit #34 |
Mississauga,
CA
L4Z 3L3
|
|
Applicant Contact |
Tammy Mui |
Correspondent |
H&A Mui Enterprises Inc. |
145 Traders Blvd. E., Unit #34 |
Mississauga,
CA
L4Z 3L3
|
|
Correspondent Contact |
Tammy Mui |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/26/2019 |
Decision Date | 02/21/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|