The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Electrosurgical Dispersive Plate.
Device ID | K760675 |
510k Number | K760675 |
Device Name: | ELECTROSURGICAL DISPERSIVE PLATE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ASPEN LABORATORIES, INC. 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 | 1976-09-17 |
Decision Date | 1976-12-28 |