The following data is part of a premarket notification filed by Modern Medical Equipment Mfg., Ltd. with the FDA for Suction Coagulator.
| Device ID | K033003 |
| 510k Number | K033003 |
| Device Name: | SUCTION COAGULATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MODERN MEDICAL EQUIPMENT MFG., LTD. TAI LIN PAI RD. Kwai Chung, Hong Kong, CN |
| Contact | David Lou |
| Correspondent | David Lou MODERN MEDICAL EQUIPMENT MFG., LTD. TAI LIN PAI RD. Kwai Chung, Hong Kong, CN |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-25 |
| Decision Date | 2004-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00192896009479 | K033003 | 000 |
| 00192896009462 | K033003 | 000 |
| 00192896009455 | K033003 | 000 |
| 00192896009448 | K033003 | 000 |
| 30841785106157 | K033003 | 000 |
| 30841785106140 | K033003 | 000 |
| 20653405059926 | K033003 | 000 |
| 30653404049930 | K033003 | 000 |
| 20653405059933 | K033003 | 000 |