510(k) K770413
K770413 is an FDA 510(k) premarket notification submitted by Combe, Inc. for the device "CUSHIONS, DENTURE ADHESIVE, ALL-DAY". The FDA issued a decision of Substantially Equivalent on June 24, 1977. The device falls under product code EHS (Cushion, Denture, Over The Counter), a Class II device regulated under 21 CFR 872.3540. Combe, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1977
- Date Received
- March 4, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cushion, Denture, Over The Counter
- Device Class
- Class II
- Regulation Number
- 872.3540
- Review Panel
- DE
- Submission Type