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510(k) K883062

Device
ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID
Applicant
ALPHA-TEC SYSTEMS, INC.
510(k) number
K883062
Product code
LDW  
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-04
Date received
1988-07-19
Regulation
864.4010
Classification name
Fixative, Acid Containing
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 LDW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842923PICRIC ACID 1% W/VE K Ind., Inc.1984-09-11
K842922PICRIC ACID SATURATED SOLUTIONE K Ind., Inc.1984-09-07
K831058SAF FIXATIVEAmerican Micro Scan1983-06-08

Legacy Summary#

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FDA Review#

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