The following data is part of a premarket notification filed by Biomed Laboratories, Inc with the FDA for Biomed Wound Cleanser.
| Device ID | K100613 |
| 510k Number | K100613 |
| Device Name: | BIOMED WOUND CLEANSER |
| Classification | Dressing, Wound, Drug |
| Applicant | BIOMED LABORATORIES, INC 2713 INDUSTRIAL LANE Garland, TX 75041 |
| Contact | Donald G White |
| Correspondent | Donald G White BIOMED LABORATORIES, INC 2713 INDUSTRIAL LANE Garland, TX 75041 |
| 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 | 2010-03-04 |
| Decision Date | 2011-01-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885380114531 | K100613 | 000 |
| 50885380114524 | K100613 | 000 |
| 50885380114517 | K100613 | 000 |