The following data is part of a premarket notification filed by Intl. Medication Systems, Ltd. with the FDA for Unicaddy I & Ii I.v. Container Caddy Ims Pole Mate.
Device ID | K860468 |
510k Number | K860468 |
Device Name: | UNICADDY I & II I.V. CONTAINER CADDY IMS POLE MATE |
Classification | Stand, Infusion |
Applicant | INTL. MEDICATION SYSTEMS, LTD. 1886 SANTA ANITA AVE. South El Monte, CA 91733 |
Contact | Diane Gillett |
Correspondent | Diane Gillett INTL. MEDICATION SYSTEMS, LTD. 1886 SANTA ANITA AVE. South El Monte, CA 91733 |
Product Code | FOX |
CFR Regulation Number | 880.6990 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-06 |
Decision Date | 1986-03-18 |