The following data is part of a premarket notification filed by Silverleaf Medical Products, Inc. with the FDA for Prosit Wound Treatment Device.
| Device ID | K081977 |
| 510k Number | K081977 |
| Device Name: | PROSIT WOUND TREATMENT DEVICE |
| Classification | Dressing, Wound, Drug |
| Applicant | SILVERLEAF MEDICAL PRODUCTS, INC. 1100 E UNIVERSITY DRIVE SUITE 101 Tempe, AZ 85281 |
| Contact | Jeffry Skiba |
| Correspondent | Jeffry Skiba 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 | 2008-07-11 |
| Decision Date | 2008-12-01 |
| Summary: | summary |