The following data is part of a premarket notification filed by Beacon Laboratories, Inc. with the FDA for Beamer One.
Device ID | K894663 |
510k Number | K894663 |
Device Name: | BEAMER ONE |
Classification | Apparatus, Electrosurgical |
Applicant | BEACON LABORATORIES, INC. 11256 QUIVAS LOOP Westminster, CO 80234 |
Contact | Richard Fleenor |
Correspondent | Richard Fleenor BEACON LABORATORIES, INC. 11256 QUIVAS LOOP Westminster, CO 80234 |
Product Code | HAM |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-24 |
Decision Date | 1989-09-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BEAMER ONE 74016970 1649381 Dead/Cancelled |
Beacon Laboratories, Inc. 1990-01-08 |