The following data is part of a premarket notification filed by Q2 Medical with the FDA for Bayonet Forceps Bipolar Irrigating.
Device ID | K002752 |
510k Number | K002752 |
Device Name: | BAYONET FORCEPS BIPOLAR IRRIGATING |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Q2 MEDICAL 2400 CRITTENDEN DR. Louisville, KY 40217 |
Contact | Eric Mills |
Correspondent | Eric Mills Q2 MEDICAL 2400 CRITTENDEN DR. Louisville, KY 40217 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-09-05 |
Decision Date | 2000-11-20 |