The following data is part of a premarket notification filed by Ndm Corp. with the FDA for Diatemp Electrosurgical Pen.
| Device ID | K853968 |
| 510k Number | K853968 |
| Device Name: | DIATEMP ELECTROSURGICAL PEN |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NDM CORP. PO BOX 1408 Dayton, OH 45401 |
| Contact | John E Shumway |
| Correspondent | John E Shumway NDM CORP. PO BOX 1408 Dayton, OH 45401 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-26 |
| Decision Date | 1985-11-14 |