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510(k) K890022

Device
ATS MAYER'S ALBUMIN
Applicant
ALPHA-TEC SYSTEMS, INC.
510(k) number
K890022
Product code
KEL  
Decision
Substantially Equivalent (SESE)
Decision date
1989-01-10
Date received
1989-01-04
Regulation
864.4010
Classification name
Adhesive, Albumin-based
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LAURIE A WILLIAMS
Address
18271 Mcdurmott W., Suite I Irvine CA US 92714 92714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KEL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881477HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTEDStat Path1988-04-18

Legacy Summary#

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FDA Review#

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