The following data is part of a premarket notification filed by Intl. Medical Industries with the FDA for Chemo-vent.
| Device ID | K860434 |
| 510k Number | K860434 |
| Device Name: | CHEMO-VENT |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | INTL. MEDICAL INDUSTRIES 570 PLEASANT ST. Watertown, MA 02172 |
| Contact | John P Vitello |
| Correspondent | John P Vitello INTL. MEDICAL INDUSTRIES 570 PLEASANT ST. Watertown, MA 02172 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-04 |
| Decision Date | 1986-02-12 |