The following data is part of a premarket notification filed by Beam Tech Ltd. with the FDA for Beam Tech Wound Dressing*.
| Device ID | K890603 |
| 510k Number | K890603 |
| Device Name: | BEAM TECH WOUND DRESSING* |
| Classification | Dressing, Wound, Drug |
| Applicant | BEAM TECH LTD. 7500 E. ARAPAHOE ROAD, STE. 250 Englewood, CO 80112 |
| Contact | Jan Daniels |
| Correspondent | Jan Daniels BEAM TECH LTD. 7500 E. ARAPAHOE ROAD, STE. 250 Englewood, CO 80112 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-06 |
| Decision Date | 1989-05-23 |