510(k) K791673

EMPTY TRANSFER BAG by Delmed, Inc. — Product Code KSR

K791673 is an FDA 510(k) premarket notification submitted by Delmed, Inc. for the device "EMPTY TRANSFER BAG". The FDA issued a decision of Substantially Equivalent on October 23, 1979. The device falls under product code KSR (Container, Empty, For Collection & Processing Of Blood & Blood Components), a Class II device regulated under 21 CFR 864.9100. Delmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1979
Date Received
August 28, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Device Class
Class II
Regulation Number
864.9100
Review Panel
HE
Submission Type