The following data is part of a premarket notification filed by Modern Medical Equipment Mfg., Ltd. with the FDA for Modern Medical Bipolar Forceps.
Device ID | K032327 |
510k Number | K032327 |
Device Name: | MODERN MEDICAL BIPOLAR FORCEPS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | MODERN MEDICAL EQUIPMENT MFG., LTD. 35 TAI LIN PAI RD. GOLD KING IND. BLDG. Kwai Chung, N.t., HK |
Contact | David Lou |
Correspondent | David Lou MODERN MEDICAL EQUIPMENT MFG., LTD. 35 TAI LIN PAI RD. GOLD KING IND. BLDG. Kwai Chung, N.t., HK |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-28 |
Decision Date | 2004-06-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10653405061403 | K032327 | 000 |
10653405061397 | K032327 | 000 |
10653405061380 | K032327 | 000 |
10653405061373 | K032327 | 000 |
10653405061366 | K032327 | 000 |
10653405061359 | K032327 | 000 |