510(k) K833515
- Device
- Bouins Solution
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K833515
- Product code
- IGN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-11-14
- Date received
- 1983-10-11
- Regulation
- 864.4010
- Classification name
- Fluid, Bouin'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#
- 3016741564
- 1419699
- 1125908
- 3008174888
- 1219125
- 3004074729
- 3007496191
- 1640981
- 2518071
- 3008572203
- 1625587
- 1831638
- 3017970519
- 3009432145
- 3006365273
- 2247035
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IGN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K822129 | VOLU-SOL BOVINS FIXATIVE | Volu Sol Medical Industries | 1982-08-05 |