The following data is part of a premarket notification filed by Deroyal Industries with the FDA for Protocol Incision Dressing.
| Device ID | K142962 |
| 510k Number | K142962 |
| Device Name: | PROTOCOL Incision Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | DEROYAL INDUSTRIES 200 DEBUSK LANE Powell, TN 37849 |
| Contact | Elizabeth Wheeler |
| Correspondent | Elizabeth Wheeler DEROYAL INDUSTRIES 200 DEBUSK LANE Powell, TN 37849 |
| 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 | 2014-10-14 |
| Decision Date | 2015-07-23 |
| Summary: | summary |