The following data is part of a premarket notification filed by Zimmar Consulting Ltd. with the FDA for Cliniset Infusion Set.
| Device ID | K860322 |
| 510k Number | K860322 |
| Device Name: | CLINISET INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | ZIMMAR CONSULTING LTD. 1801 MCGILL COLLEGE AVENUE, SUITE 1470 Montreal, Canada H3a2n4, CA |
| Contact | Douglas M Bennett |
| Correspondent | Douglas M Bennett ZIMMAR CONSULTING LTD. 1801 MCGILL COLLEGE AVENUE, SUITE 1470 Montreal, Canada H3a2n4, CA |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-29 |
| Decision Date | 1986-04-07 |