510(k) K790409

LOW DEAD SPACE INSULIN SYRINGE by Pharmaseal Div., Baxter Healthcare Corp. — Product Code FMF

K790409 is an FDA 510(k) premarket notification submitted by Pharmaseal Div., Baxter Healthcare Corp. for the device "LOW DEAD SPACE INSULIN SYRINGE". The FDA issued a decision of Substantially Equivalent on April 24, 1979. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Pharmaseal Div., Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1979
Date Received
February 26, 1979
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