The following data is part of a premarket notification filed by Porges Corp. with the FDA for Modified Pediatric Silicone Foley Catheters.
| Device ID | K900031 |
| 510k Number | K900031 |
| Device Name: | MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS |
| Classification | Accessories, Catheter, G-u |
| Applicant | PORGES CORP. 5700 WEST 23RD AVE. Gary, IN 46406 |
| Contact | Harry M Kaufman |
| Correspondent | Harry M Kaufman PORGES CORP. 5700 WEST 23RD AVE. Gary, IN 46406 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-04 |
| Decision Date | 1990-03-06 |