The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Charles Endocoagulator Accessory For Arc.
Device ID | K780851 |
510k Number | K780851 |
Device Name: | CHARLES ENDOCOAGULATOR ACCESSORY FOR ARC |
Classification | Clamp, Muscle, Ophthalmic |
Applicant | VARIAN ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HOB |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-05-22 |
Decision Date | 1978-06-30 |