The following data is part of a premarket notification filed by Rand Scientific Corp. with the FDA for Rand Nasal Packing.
| Device ID | K963856 |
| 510k Number | K963856 |
| Device Name: | RAND NASAL PACKING |
| Classification | Balloon, Epistaxis |
| Applicant | RAND SCIENTIFIC CORP. 4135 NORTHGATE BLVD., SUITE 9 Sacramento, CA 95834 |
| Contact | Duane Tracy |
| Correspondent | Duane Tracy RAND SCIENTIFIC CORP. 4135 NORTHGATE BLVD., SUITE 9 Sacramento, CA 95834 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-25 |
| Decision Date | 1996-10-18 |