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 |