510(k) K941365
K941365 is an FDA 510(k) premarket notification submitted by Medical Polymers, Inc. for the device "MPI DENTURE ADHESIVE FILM SEALS". The FDA issued a decision of Substantially Equivalent on April 22, 1994. The device falls under product code KOT (Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium), a Class I device regulated under 21 CFR 872.3490. Medical Polymers, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 1994
- Date Received
- March 21, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
- Device Class
- Class I
- Regulation Number
- 872.3490
- Review Panel
- DE
- Submission Type