The following data is part of a premarket notification filed by Apogee, Inc. with the FDA for Urological Catheter.
| Device ID | K992137 |
| 510k Number | K992137 |
| Device Name: | UROLOGICAL CATHETER |
| Classification | Catheter, Urethral |
| Applicant | APOGEE, INC. 7517-101 PRECISION DR. Raleigh, NC 27613 |
| Contact | Brent D Robling |
| Correspondent | Brent D Robling APOGEE, INC. 7517-101 PRECISION DR. Raleigh, NC 27613 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-24 |
| Decision Date | 1999-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610075177049 | K992137 | 000 |
| 00610075068968 | K992137 | 000 |
| 00610075068944 | K992137 | 000 |
| 00610075068975 | K992137 | 000 |
| 00610075068951 | K992137 | 000 |
| 00610075068937 | K992137 | 000 |
| 10610075069047 | K992137 | 000 |
| 10610075068590 | K992137 | 000 |
| 10610075068576 | K992137 | 000 |
| 10610075068538 | K992137 | 000 |
| 00610075068999 | K992137 | 000 |
| 00610075069002 | K992137 | 000 |
| 10610075176721 | K992137 | 000 |
| 10610075177025 | K992137 | 000 |
| 10610075177001 | K992137 | 000 |
| 10610075176981 | K992137 | 000 |
| 10610075176868 | K992137 | 000 |
| 10610075176851 | K992137 | 000 |
| 10610075176844 | K992137 | 000 |
| 10610075176837 | K992137 | 000 |
| 10610075176776 | K992137 | 000 |
| 10610075176769 | K992137 | 000 |
| 10610075068491 | K992137 | 000 |