510(k) K934184
K934184 is an FDA 510(k) premarket notification submitted by Scientific Pharmaceuticals, Inc. for the device "FASTFIL". The FDA issued a decision of Substantially Equivalent on December 13, 1993. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Scientific Pharmaceuticals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 1993
- Date Received
- August 27, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type