The following data is part of a premarket notification filed by Medical Support Systems with the FDA for Mix Container W/attached Transfer Set.
Device ID | K885173 |
510k Number | K885173 |
Device Name: | MIX CONTAINER W/ATTACHED TRANSFER SET |
Classification | Container, I.v. |
Applicant | MEDICAL SUPPORT SYSTEMS 9825 LACKMAN RD. Lenexa, KS 66215 |
Contact | Loren Gottschalk |
Correspondent | Loren Gottschalk MEDICAL SUPPORT SYSTEMS 9825 LACKMAN RD. Lenexa, KS 66215 |
Product Code | KPE |
CFR Regulation Number | 880.5025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-13 |
Decision Date | 1989-06-07 |