510(k) K790339
K790339 is an FDA 510(k) premarket notification submitted by Richardson Merrel, Inc. for the device "CONCEPT II". The FDA issued a decision of Substantially Equivalent on July 17, 1979. The device falls under product code EBE (Coating, Denture Hydrophilic, Resin), a Class II device regulated under 21 CFR 872.3300. Richardson Merrel, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1979
- Date Received
- February 21, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Denture Hydrophilic, Resin
- Device Class
- Class II
- Regulation Number
- 872.3300
- Review Panel
- DE
- Submission Type