The following data is part of a premarket notification filed by M-pact Worldwide Management Corp. with the FDA for Ivalon Nasal Packing W/drawstring (8.0cm & 4.5cm), Ivalon Nasal Packing W/airway Tube & Drawstring, Ivalon Contour Nasal.
| Device ID | K964113 |
| 510k Number | K964113 |
| Device Name: | IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL |
| Classification | Balloon, Epistaxis |
| Applicant | M-PACT WORLDWIDE MANAGEMENT CORP. 1040 OCL PKWY. P.O. BOX 618 Eudora, KS 66025 |
| Contact | Mary Schmalz |
| Correspondent | Mary Schmalz M-PACT WORLDWIDE MANAGEMENT CORP. 1040 OCL PKWY. P.O. BOX 618 Eudora, KS 66025 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1996-11-07 |
| Summary: | summary |