The following data is part of a premarket notification filed by Beacon Laboratories, Inc. with the FDA for Beamer 1,2,4,6, And 8.
Device ID | K903724 |
510k Number | K903724 |
Device Name: | BEAMER 1,2,4,6, AND 8 |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | BEACON LABORATORIES, INC. 2150 WEST 6TH AVE., UNIT P Broomfield, CO 80020 |
Contact | Richard P Fleenor |
Correspondent | Richard P Fleenor BEACON LABORATORIES, INC. 2150 WEST 6TH AVE., UNIT P Broomfield, CO 80020 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-16 |
Decision Date | 1990-09-28 |