The following data is part of a premarket notification filed by Modern Medical Equipment Mfg., Ltd. with the FDA for Disposable Suction And Irrigation System.
| Device ID | K093479 |
| 510k Number | K093479 |
| Device Name: | DISPOSABLE SUCTION AND IRRIGATION SYSTEM |
| Classification | System, Evacuator, Fluid |
| Applicant | MODERN MEDICAL EQUIPMENT MFG., LTD. DONG XING INDUSTRIAL AREA KANG LE LU, SHAN XIA DISTRICT Heng Li, Dongguan, Guangdong, CN 523466 |
| Contact | Eugene Yeung |
| Correspondent | Eugene Yeung MODERN MEDICAL EQUIPMENT MFG., LTD. DONG XING INDUSTRIAL AREA KANG LE LU, SHAN XIA DISTRICT Heng Li, Dongguan, Guangdong, CN 523466 |
| Product Code | FHF |
| CFR Regulation Number | 876.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-09 |
| Decision Date | 2010-05-19 |
| Summary: | summary |