The following data is part of a premarket notification filed by Eschmann Bros. & Walsh Ltd. with the FDA for Eschmann Electrosurgical Unit, Model Td411.
Device ID | K852935 |
510k Number | K852935 |
Device Name: | ESCHMANN ELECTROSURGICAL UNIT, MODEL TD411 |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ESCHMANN BROS. & WALSH LTD. PETER ROAD, LANCING Sussex Bn15 8tj, GB |
Contact | V. J Cooper |
Correspondent | V. J Cooper ESCHMANN BROS. & WALSH LTD. PETER ROAD, LANCING Sussex Bn15 8tj, GB |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-10 |
Decision Date | 1985-10-10 |