The following data is part of a premarket notification filed by Pro-med Instruments Gmbh with the FDA for Doro Non-stick Bipolar Forceps, Model 5001-xx To 5012-xx, Doro Bipolar Reusable Cables, Model 5015-xx.
Device ID | K070997 |
510k Number | K070997 |
Device Name: | DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | PRO-MED INSTRUMENTS GMBH 5450 LEE ST, STE 1 Lehigh Acres, FL 33971 |
Contact | Edgar Schuele |
Correspondent | Edgar Schuele PRO-MED INSTRUMENTS GMBH 5450 LEE ST, STE 1 Lehigh Acres, FL 33971 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-04-09 |
Decision Date | 2007-05-16 |
Summary: | summary |