The following data is part of a premarket notification filed by Medical And Scientific Enterprises, Inc. with the FDA for Polyscan Digital Scanner.
| Device ID | K882453 |
| 510k Number | K882453 |
| Device Name: | POLYSCAN DIGITAL SCANNER |
| Classification | Scanner, Rectilinear, Nuclear |
| Applicant | MEDICAL AND SCIENTIFIC ENTERPRISES, INC. 56 UNION AVE. P.O. BOX 806 Sudbury, MA 01776 |
| Contact | Eduard J Botz |
| Correspondent | Eduard J Botz MEDICAL AND SCIENTIFIC ENTERPRISES, INC. 56 UNION AVE. P.O. BOX 806 Sudbury, MA 01776 |
| Product Code | IYW |
| CFR Regulation Number | 892.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-14 |
| Decision Date | 1988-11-23 |