510(k) K894177

NEEDLE*LESS DRUG VIAL ADAPTER by Baxter Healthcare Corp — Product Code FMF

K894177 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "NEEDLE*LESS DRUG VIAL ADAPTER". The FDA issued a decision of Substantially Equivalent on Sep 12, 1989. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 12, 1989
Date Received
Jun 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type
510(k)

Source: FDA 510(k) database entry for K894177. Report a data issue: hello@regdatalab.com.