The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for System 7500 Abc Electrosurgical Unit.
| Device ID | K981220 |
| 510k Number | K981220 |
| Device Name: | SYSTEM 7500 ABC ELECTROSURGICAL UNIT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ASPEN LABORATORIES, INC. 14603 E. FREMONT AVE. Englewood, CO 80112 |
| Contact | Charles (mike) M Hart |
| Correspondent | Charles (mike) M Hart ASPEN LABORATORIES, INC. 14603 E. FREMONT AVE. Englewood, CO 80112 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-03 |
| Decision Date | 1998-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40653405033593 | K981220 | 000 |
| 10653405069096 | K981220 | 000 |