510(k) K862876
K862876 is an FDA 510(k) premarket notification submitted by Block Drug Company, Inc. for the device "NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM". The FDA issued a decision of Substantially Equivalent on August 29, 1986. The device falls under product code KOO (Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt), a Class I device regulated under 21 CFR 872.3490. Block Drug Company, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 1986
- Date Received
- July 30, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
- Device Class
- Class I
- Regulation Number
- 872.3490
- Review Panel
- DE
- Submission Type