The following data is part of a premarket notification filed by Geritrex Corp. with the FDA for Geritrex Sterile Saline Solution For Irrigation.
| Device ID | K931509 |
| 510k Number | K931509 |
| Device Name: | GERITREX STERILE SALINE SOLUTION FOR IRRIGATION |
| Classification | Catheter And Tip, Suction |
| Applicant | GERITREX CORP. 2 EAST SANFORD BLVD. Mount Vernon, NY 10550 -4510 |
| Contact | Anthony Madaio |
| Correspondent | Anthony Madaio GERITREX CORP. 2 EAST SANFORD BLVD. Mount Vernon, NY 10550 -4510 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-26 |
| Decision Date | 1994-09-22 |