The following data is part of a premarket notification filed by Invotec International, Inc. with the FDA for Epistaxis Nasal Pack.
| Device ID | K971000 |
| 510k Number | K971000 |
| Device Name: | EPISTAXIS NASAL PACK |
| Classification | Balloon, Epistaxis |
| Applicant | INVOTEC INTERNATIONAL, INC. 11243-1 ST. JOHNS INDUSTRIAL PKWY. SOUTH Jacksonville, FL 32246 |
| Contact | Jeffrey L Aull |
| Correspondent | Jeffrey L Aull INVOTEC INTERNATIONAL, INC. 11243-1 ST. JOHNS INDUSTRIAL PKWY. SOUTH Jacksonville, FL 32246 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-19 |
| Decision Date | 1997-05-14 |