The following data is part of a premarket notification filed by Porges Corp. with the FDA for Spec 5* Suprapubic Catheter.
| Device ID | K881097 |
| 510k Number | K881097 |
| Device Name: | SPEC 5* SUPRAPUBIC CATHETER |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | PORGES CORP. 56 WESTCOTT RD. Stamford, CT 06902 |
| Contact | Cornelia Damsky |
| Correspondent | Cornelia Damsky PORGES CORP. 56 WESTCOTT RD. Stamford, CT 06902 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-15 |
| Decision Date | 1988-06-03 |