The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Industries, Inc. Polyderm & Polyderm Border Foam Wound Dressings.
| Device ID | K953403 |
| 510k Number | K953403 |
| Device Name: | DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS |
| Classification | Bandage, Liquid |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-20 |
| Decision Date | 1995-10-06 |