510(k) K900651

TS-1800 MEDICATION TRANSFER SPIKE by The Medi-Dose Group — Product Code FPA

K900651 is an FDA 510(k) premarket notification submitted by The Medi-Dose Group for the device "TS-1800 MEDICATION TRANSFER SPIKE". The FDA issued a decision of Substantially Equivalent on May 7, 1990. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. The Medi-Dose Group has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1990
Date Received
Feb 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type