510(k) K882874
- Device
- ZINC FORMALIN
- Applicant
- ANATECH, LTD.
- 510(k) number
- K882874
- Product code
- LDX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-07-28
- Date received
- 1988-07-11
- Regulation
- 864.4010
- Classification name
- Fixative, Metallic Containing
- 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#
- 1831312
- 3017970519
- 3006365273
- 3003703247
- 1924669
- 2013736
- 1524213
- 1625587
- 1125908
- 3008174888
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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