The following data is part of a premarket notification filed by Porges Catheter Corp. with the FDA for Glassman-dormia Gallstone Extractor Set.
| Device ID | K811580 |
| 510k Number | K811580 |
| Device Name: | GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | PORGES CATHETER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-05 |
| Decision Date | 1981-06-26 |