510(k) K771120
- Device
- IMPREFLEX ALGINATE IMPRESSION MATERIAL
- Applicant
- Espe Dental Products
- 510(k) number
- K771120
- Product code
- LEW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-03
- Date received
- 1977-06-22
- Regulation
- 862.3880
- Classification name
- Thin Layer Chromatography, Theophylline
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents
510(k) summary PDF not indicated by FDA