The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Diathermic Snare (cresent Type).
Device ID | K792343 |
510k Number | K792343 |
Device Name: | DIATHERMIC SNARE (CRESENT TYPE) |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | MILL-ROSE LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-19 |
Decision Date | 1979-12-18 |