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 |