510(k) K930217

BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE by Baxter Healthcare Corp — Product Code FMI

K930217 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE". The FDA issued a decision of Substantially Equivalent on Feb 28, 1994. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 28, 1994
Date Received
Jan 15, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type
510(k)

Source: FDA 510(k) database entry for K930217. Report a data issue: hello@regdatalab.com.