510(k) K882453
K882453 is an FDA 510(k) premarket notification submitted by Medical and Scientific Enterprises, Inc. for the device "POLYSCAN DIGITAL SCANNER". The FDA issued a decision of Substantially Equivalent on November 23, 1988. The device falls under product code IYW (Scanner, Rectilinear, Nuclear), a Class I device regulated under 21 CFR 892.1300. Medical and Scientific Enterprises, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 1988
- Date Received
- June 14, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scanner, Rectilinear, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1300
- Review Panel
- RA
- Submission Type