The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Simplastic Foley Catheterization Set.
| Device ID | K963993 |
| 510k Number | K963993 |
| Device Name: | RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-04 |
| Decision Date | 1996-12-17 |
| Summary: | summary |