The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Brillant Silicone Foley.
| Device ID | K993063 |
| 510k Number | K993063 |
| Device Name: | RUSCH BRILLANT SILICONE FOLEY |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Julie A Beaumont |
| Correspondent | Julie A Beaumont RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-13 |
| Decision Date | 1999-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704022104 | K993063 | 000 |
| 24026704022094 | K993063 | 000 |