The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Modified Porges Spec 5* Suprapubic Catheter.
| Device ID | K901603 |
| 510k Number | K901603 |
| Device Name: | MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Contact | Harry M Kaufman |
| Correspondent | Harry M Kaufman BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-27 |
| Decision Date | 1990-05-04 |