The following data is part of a premarket notification filed by Enable Medical Corp. with the FDA for Oscar Bipolar Scissors And Oscar Bipolar Reusable Cartridges.
| Device ID | K981219 |
| 510k Number | K981219 |
| Device Name: | OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENABLE MEDICAL CORP. 6345 CENTRE PARK DR. West Chester, OH 45069 -3863 |
| Contact | Mark L Friedman, Phd |
| Correspondent | Mark L Friedman, Phd 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 | 1998-04-03 |
| Decision Date | 1998-06-29 |
| Summary: | summary |