The following data is part of a premarket notification filed by H&a Mui Enterprises Inc. with the FDA for Patcom Single-use Introducer.
| Device ID | K192691 |
| 510k Number | K192691 |
| Device Name: | PatCom Single-Use Introducer |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | H&A Mui Enterprises Inc. 145 Traders Blvd. E., Unit #34 Mississauga, CA L4z 3l3 |
| Contact | Tammy Mui |
| Correspondent | Tammy Mui H&A Mui Enterprises Inc. 145 Traders Blvd. E., Unit #34 Mississauga, CA L4z 3l3 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-26 |
| Decision Date | 2020-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00678467507068 | K192691 | 000 |
| 00678467507495 | K192691 | 000 |
| 00678467506870 | K192691 | 000 |