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 |