510(k) K822127
- Device
- VOLU-SOL ZENKERS FIXATIVE
- Applicant
- VOLU SOL MEDICAL INDUSTRIES
- 510(k) number
- K822127
- Product code
- IFH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-05
- Date received
- 1982-07-19
- Regulation
- 864.4010
- Classification name
- Solution, Zenker's
- 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
FDA Registration Numbers#
- 1419699
- 1125908
- 3008174888
- 1625587
- 3006365273
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IFH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842732 | ZENKERS SOLUTION | E K Ind., Inc. | 1984-08-03 |
Legacy Summary#
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FDA Review#
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