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510(k) K882268

Device
ZINC FORMALIN CONCENTRATE
Applicant
ANATECH, LTD.
510(k) number
K882268
Product code
IGG  
Decision
Substantially Equivalent (SESE)
Decision date
1988-06-15
Date received
1988-05-31
Regulation
864.4010
Classification name
Formaldehyde (formalin, Formol)
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
FELDMAN, M.S.
Address
1020 Harts Lake Rd. Battle Creek MI US 49015 49015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IGG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K861201FORMALDEHYDE SOLUTION, 37%Surgipath Medical Industries, Inc.1986-04-11
K81179437% FORMALDEHYDERichard-Allan Medical Ind., Inc.1981-07-28
K802506PLEASCENT OR FORMA-SCENTMeridian Diagnostics, Inc.1980-11-12
K792705PARA-PAK FORMALINMeridian Diagnostics, Inc.1980-01-21
K792707PARA-PAK SAFMeridian Diagnostics, Inc.1980-01-21
K771201FORMALIN BUFFER CONCENTRATECentral Labs. Assoc. MD Pathologists1977-08-22

Legacy Summary#

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FDA Review#

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