The following data is part of a premarket notification filed by American Biosurgical, Inc. with the FDA for American Biosurgical Electrosurgical Bipolar Cable/cord.
| Device ID | K953889 |
| 510k Number | K953889 |
| Device Name: | AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AMERICAN BIOSURGICAL, INC. 6665-B CORNERS INDUSTRIAL CT. Norcross, GA 30092 |
| Contact | Michael Socoloff |
| Correspondent | Michael Socoloff AMERICAN BIOSURGICAL, INC. 6665-B CORNERS INDUSTRIAL CT. Norcross, GA 30092 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-17 |
| Decision Date | 1995-10-18 |