The following data is part of a premarket notification filed by Novamed, Llc with the FDA for Novamed Mri Conditional Laryngoscope Set.
| Device ID | K063477 |
| 510k Number | K063477 |
| Device Name: | NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET |
| Classification | Laryngoscope, Rigid |
| Applicant | NOVAMED, LLC 3460 POINTE CREEK CT. #102 Bonita Springs, FL 34134 -2015 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden NOVAMED, LLC 3460 POINTE CREEK CT. #102 Bonita Springs, FL 34134 -2015 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-16 |
| Decision Date | 2007-02-09 |
| Summary: | summary |