The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Urological Catheter & Accessories.
| Device ID | K951178 |
| 510k Number | K951178 |
| Device Name: | UROLOGICAL CATHETER & ACCESSORIES |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Deborah F Manning |
| Correspondent | Deborah F Manning DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-15 |
| Decision Date | 1995-04-21 |