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 |