The following data is part of a premarket notification filed by Porges Corp. with the FDA for Porges Stepped Neoplex Dilator.
| Device ID | K883526 |
| 510k Number | K883526 |
| Device Name: | PORGES STEPPED NEOPLEX DILATOR |
| Classification | Dilator, Esophageal |
| 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 | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-18 |
| Decision Date | 1988-10-28 |