The following data is part of a premarket notification filed by Denver Splint Co. with the FDA for The Expandacell Sinus Pack.
| Device ID | K935724 |
| 510k Number | K935724 |
| Device Name: | THE EXPANDACELL SINUS PACK |
| Classification | Balloon, Epistaxis |
| Applicant | DENVER SPLINT CO. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood, CO 80112 |
| Contact | Sarah M Lake |
| Correspondent | Sarah M Lake DENVER SPLINT CO. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood, CO 80112 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-01 |
| Decision Date | 1994-05-12 |