The following data is part of a premarket notification filed by Innovations By Necessity, Inc. with the FDA for Innovations Nasal Tampon.
| Device ID | K896248 |
| 510k Number | K896248 |
| Device Name: | INNOVATIONS NASAL TAMPON |
| Classification | Balloon, Epistaxis |
| Applicant | INNOVATIONS BY NECESSITY, INC. 3334 EAST COAST HWY., SUITE 128 Corona Del Mar, CA 92625 |
| Contact | Karen Bendt |
| Correspondent | Karen Bendt INNOVATIONS BY NECESSITY, INC. 3334 EAST COAST HWY., SUITE 128 Corona Del Mar, CA 92625 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-30 |
| Decision Date | 1990-04-13 |