510(k) K771120
K771120 is an FDA 510(k) premarket notification submitted by Espe Dental Products for the device "IMPREFLEX ALGINATE IMPRESSION MATERIAL". The FDA issued a decision of Substantially Equivalent on August 3, 1977. The device falls under product code LEW (Thin Layer Chromatography, Theophylline), a Class II device regulated under 21 CFR 862.3880. Espe Dental Products has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1977
- Date Received
- June 22, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thin Layer Chromatography, Theophylline
- Device Class
- Class II
- Regulation Number
- 862.3880
- Review Panel
- TX
- Submission Type