The following data is part of a premarket notification filed by Denver Splint Co. with the FDA for The Expandacell Ear Pack.
| Device ID | K940133 |
| 510k Number | K940133 |
| Device Name: | THE EXPANDACELL EAR PACK |
| Classification | Applicator, Ent Drug |
| Applicant | DENVER SPLINT CO. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood, CO 80112 |
| Contact | Sarah Maxwell Lake |
| Correspondent | Sarah Maxwell Lake DENVER SPLINT CO. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood, CO 80112 |
| Product Code | LRD |
| CFR Regulation Number | 874.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-03 |
| Decision Date | 1994-05-23 |