510(k) K760914

Device: Double Elutra-pack Unit
Applicant: TRAVENOL LABORATORIES, S.A.
510(k) number: K760914
Product code: KSW
Decision: Substantially Equivalent (SESE)
Decision date: 1976-11-23
Date received: 1976-10-27
Regulation: 864.9145
Classification name: System, Processing For Frozen Blood
Medical specialty: Hematology
Review panel: Hematology
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

3004548776
1019003
1416980
1722028
9617787
1025114
3019807891
3007923088
3003704957
1219343
2032112
2029015

Source Documents#

510(k) summary PDF not indicated by FDA