The following data is part of a premarket notification filed by Birtcher Corp. with the FDA for Birt-a-switch Dsp #712.
Device ID | K823491 |
510k Number | K823491 |
Device Name: | BIRT-A-SWITCH DSP #712 |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | BIRTCHER CORP. 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 | 1982-11-23 |
Decision Date | 1983-01-07 |