510(k) K842862
- Device
- CB FORMALIN
- Applicant
- ANATECH, LTD.
- 510(k) number
- K842862
- Product code
- IGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-08-28
- Date received
- 1984-07-23
- Regulation
- 864.4010
- Classification name
- Solution, Formalin Ammonium Bromide
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IGE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950560 | SALINE SOLUTINE, STERILE | Busse Hospital Disposables, Inc. | 1995-05-30 |
Legacy Summary#
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FDA Review#
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