The following data is part of a premarket notification filed by Birtcher Corp. with the FDA for Birt-a-switch, Dsp Push Button, Model No. 768.
Device ID | K860687 |
510k Number | K860687 |
Device Name: | BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768 |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | BIRTCHER CORP. 4501 N. ARDEN DR. P.O. BOX 4399 El Monte, CA 91731 |
Contact | Donald L Emmons |
Correspondent | Donald L Emmons BIRTCHER CORP. 4501 N. ARDEN DR. P.O. BOX 4399 El Monte, CA 91731 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-25 |
Decision Date | 1986-03-24 |