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 |