The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Electrosurgical Unit-mf 380 #60-1700.
| Device ID | K831291 |
| 510k Number | K831291 |
| Device Name: | ELECTROSURGICAL UNIT-MF 380 #60-1700 |
| 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 | 1983-04-20 |
| Decision Date | 1983-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30653405043946 | K831291 | 000 |
| 30653405009164 | K831291 | 000 |
| 20653405008900 | K831291 | 000 |
| 10653405009160 | K831291 | 000 |