The following data is part of a premarket notification filed by Surgitrend, Ltd. with the FDA for Expandacel Nasal Tampons, Modification.
| Device ID | K912524 |
| 510k Number | K912524 |
| Device Name: | EXPANDACEL NASAL TAMPONS, MODIFICATION |
| Classification | Balloon, Epistaxis |
| Applicant | SURGITREND, LTD. 6099 SOUTH QUEBEC ST. #200 Englewood, CO 80111 |
| Contact | Ron Shipperet |
| Correspondent | Ron Shipperet SURGITREND, LTD. 6099 SOUTH QUEBEC ST. #200 Englewood, CO 80111 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-03 |
| Decision Date | 1991-08-15 |