The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Portage System.
| Device ID | K161878 |
| 510k Number | K161878 |
| Device Name: | PORTAGE System |
| Classification | Arthroscope |
| Applicant | Baylis Medical Company Inc. 2645 Matheson Blvd. East Mississauga, CA L4w 5s4 |
| Contact | Meghal Khakhar |
| Correspondent | Meghal Khakhar Baylis Medical Company Inc. 2645 Matheson Blvd. East Mississauga, CA L4w 5s4 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-08 |
| Decision Date | 2016-09-26 |
| Summary: | summary |