The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Supraflex Suprapubic Cystostomy Catheter Kit, Sterile.
| Device ID | K952187 |
| 510k Number | K952187 |
| Device Name: | RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE |
| Classification | Catheter, Suprapubic (and Accessories) |
| 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 | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-09 |
| Decision Date | 1995-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704066122 | K952187 | 000 |
| 24026704437225 | K952187 | 000 |
| 44026704437212 | K952187 | 000 |
| 44026704437205 | K952187 | 000 |
| 24026704020809 | K952187 | 000 |