The following data is part of a premarket notification filed by Inmed Corp. with the FDA for Bristol Ballon Introducer, Mandril Set.
| Device ID | K813332 |
| 510k Number | K813332 |
| Device Name: | BRISTOL BALLON INTRODUCER, MANDRIL SET |
| Classification | Endoscope Introducer Kit |
| Applicant | INMED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | NWU |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-24 |
| Decision Date | 1981-12-14 |