The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Eschmann Tdb50 Bipolar Coagulation.
| Device ID | K844004 |
| 510k Number | K844004 |
| Device Name: | ESCHMANN TDB50 BIPOLAR COAGULATION |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Niles Ross |
| Correspondent | Niles Ross STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-12 |
| Decision Date | 1984-12-12 |