The following data is part of a premarket notification filed by Promedicon, Inc. with the FDA for Electrosurgical Disp. Dispersive Pad.
Device ID | K820196 |
510k Number | K820196 |
Device Name: | ELECTROSURGICAL DISP. DISPERSIVE PAD |
Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
Applicant | PROMEDICON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNS |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-25 |
Decision Date | 1982-02-12 |