510(k) K850610
K850610 is an FDA 510(k) premarket notification submitted by Lever Brothers Company, Inc. for the device "PEPSODENT DENTURE ADHESIVE CREAM". The FDA issued a decision of Substantially Equivalent on May 15, 1985. The device falls under product code EBD (Coating, Filling Material, Resin), a Class II device regulated under 21 CFR 872.3310. Lever Brothers Company, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 1985
- Date Received
- February 15, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Filling Material, Resin
- Device Class
- Class II
- Regulation Number
- 872.3310
- Review Panel
- DE
- Submission Type