510(k) K893787

LIFECELL RECOVERY CONTAINER by Baxter Healthcare Corp — Product Code KJF

K893787 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "LIFECELL RECOVERY CONTAINER". The FDA issued a decision of Substantially Equivalent on June 23, 1989. The device falls under product code KJF (System, Suspension, Cell Culture), a Class I device regulated under 21 CFR 864.2240. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1989
Date Received
May 22, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Suspension, Cell Culture
Device Class
Class I
Regulation Number
864.2240
Review Panel
PA
Submission Type