The following data is part of a premarket notification filed by Resmed Sas with the FDA for Narval Cc.
| Device ID | K113201 |
| 510k Number | K113201 |
| Device Name: | NARVAL CC |
| Classification | Device, Jaw Repositioning |
| Applicant | RESMED SAS 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
| Contact | David D'cruz |
| Correspondent | David D'cruz RESMED SAS 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
| Product Code | LQZ |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2011-12-01 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NARVAL CC 85489200 not registered Dead/Abandoned |
ResMed SAS 2011-12-07 |