The following data is part of a premarket notification filed by Comfortable Concepts Corp. with the FDA for The Comfortable Cannula.
| Device ID | K896036 |
| 510k Number | K896036 |
| Device Name: | THE COMFORTABLE CANNULA |
| Classification | Cannula, Nasal, Oxygen |
| Applicant | COMFORTABLE CONCEPTS CORP. 102 RALPH AVE. Copiague, NY 11726 |
| Contact | Andrew N Weiss |
| Correspondent | Andrew N Weiss COMFORTABLE CONCEPTS CORP. 102 RALPH AVE. Copiague, NY 11726 |
| Product Code | CAT |
| CFR Regulation Number | 868.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-17 |
| Decision Date | 1989-11-17 |