The following data is part of a premarket notification filed by Ritter Co. with the FDA for Electrosurgical Unit 75.
Device ID | K781101 |
510k Number | K781101 |
Device Name: | ELECTROSURGICAL UNIT 75 |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | RITTER CO. 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 | 1978-07-03 |
Decision Date | 1978-07-17 |