The following data is part of a premarket notification filed by Silverleaf Medical Products, Inc. with the FDA for Cmb Antimicrobial Dressing.
| Device ID | K060237 |
| 510k Number | K060237 |
| Device Name: | CMB ANTIMICROBIAL DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | SILVERLEAF MEDICAL PRODUCTS, INC. 1100 E UNIVERSITY DRIVE SUITE 101 Tempe, AZ 85281 |
| Contact | Debbie Koeneman |
| Correspondent | Debbie Koeneman SILVERLEAF MEDICAL PRODUCTS, INC. 1100 E UNIVERSITY DRIVE SUITE 101 Tempe, AZ 85281 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-01-30 |
| Decision Date | 2006-06-15 |
| Summary: | summary |