The following data is part of a premarket notification filed by Enable Medical Corp. with the FDA for Bipolar Coagulation System.
| Device ID | K010112 |
| 510k Number | K010112 |
| Device Name: | BIPOLAR COAGULATION SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENABLE MEDICAL CORP. 6345 CENTRE PARK DR. West Chester, OH 45069 -3863 |
| Contact | Mark L Friedman |
| Correspondent | Mark L Friedman ENABLE MEDICAL CORP. 6345 CENTRE PARK DR. West Chester, OH 45069 -3863 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-12 |
| Decision Date | 2001-04-02 |