The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Beamer Plus.
| Device ID | K953081 |
| 510k Number | K953081 |
| Device Name: | BEAMER PLUS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ASPEN LABORATORIES, INC. 7211 SOUTH EAGLE ST. Englewood, CO 80112 |
| Contact | Charles M Hart |
| Correspondent | Charles M Hart ASPEN LABORATORIES, INC. 7211 SOUTH EAGLE ST. 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 | 1995-07-03 |
| Decision Date | 1995-10-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BEAMER PLUS 74727089 2049915 Dead/Cancelled |
CONMED CORPORATION 1995-09-11 |