The following data is part of a premarket notification filed by Birtcher Corp. with the FDA for Model 738 Birt-a-pad.
Device ID | K761231 |
510k Number | K761231 |
Device Name: | MODEL 738 BIRT-A-PAD |
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 | 1976-12-10 |
Decision Date | 1977-01-14 |