The following data is part of a premarket notification filed by Modern Medical Equipment Mfg., Ltd. with the FDA for Softseal Hsg Catheter.
| Device ID | K040238 |
| 510k Number | K040238 |
| Device Name: | SOFTSEAL HSG CATHETER |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | MODERN MEDICAL EQUIPMENT MFG., LTD. 1705 DABNEY RD. Richmond, VA 23230 |
| Contact | Al Muzzammel |
| Correspondent | Al Muzzammel MODERN MEDICAL EQUIPMENT MFG., LTD. 1705 DABNEY RD. Richmond, VA 23230 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-26 |
| Decision Date | 2004-06-22 |