The following data is part of a premarket notification filed by Sol-millennium Medical Group with the FDA for Sol-care Iv Bag Safety Connector.
Device ID | K202732 |
510k Number | K202732 |
Device Name: | SOL-CARE IV Bag Safety Connector |
Classification | Set, I.v. Fluid Transfer |
Applicant | Sol-Millennium Medical Group 315 Shawnee North Drive, Suite 100 Suwanne, GA 30024 |
Contact | Jim Barley |
Correspondent | Jim Barley Sol-Millennium Medical Group 315 Shawnee North Drive, Suite 100 Suwanne, GA 30024 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-18 |
Decision Date | 2021-11-03 |