The following data is part of a premarket notification filed by Surgitrend, Ltd. with the FDA for Expandacel Nasal Tampons.
| Device ID | K900171 |
| 510k Number | K900171 |
| Device Name: | EXPANDACEL NASAL TAMPONS |
| Classification | Balloon, Epistaxis |
| Applicant | SURGITREND, LTD. 6099 SOUTH QUEBEC ST. #200 Englewood, CO 80111 |
| Contact | Shippert, Md |
| Correspondent | Shippert, Md 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 | 1990-01-12 |
| Decision Date | 1990-06-14 |