The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Electrosurgical Power Generators.
| Device ID | K771007 |
| 510k Number | K771007 |
| Device Name: | ELECTROSURGICAL POWER GENERATORS |
| 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 | 1977-06-03 |
| Decision Date | 1977-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30653405011266 | K771007 | 000 |
| 30653405008143 | K771007 | 000 |
| 10653405008545 | K771007 | 000 |