The following data is part of a premarket notification filed by Medical Scientific, Inc. with the FDA for Css.
| Device ID | K031564 |
| 510k Number | K031564 |
| Device Name: | CSS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDICAL SCIENTIFIC, INC. 125 JOHN HANCOCK RD. Taunton, MA 02780 |
| Contact | Paul Nardella |
| Correspondent | Paul Nardella MEDICAL SCIENTIFIC, INC. 125 JOHN HANCOCK RD. Taunton, MA 02780 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-19 |
| Decision Date | 2003-10-07 |
| Summary: | summary |