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 | K972901 |
| 510k Number | K972901 |
| 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 | 1997-08-06 |
| Decision Date | 1997-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190776123314 | K972901 | 000 |
| 00849593019729 | K972901 | 000 |
| 00849593019897 | K972901 | 000 |
| 00849593019910 | K972901 | 000 |
| 00852028007109 | K972901 | 000 |
| 00852028007116 | K972901 | 000 |
| 00852028007147 | K972901 | 000 |
| 00852028007154 | K972901 | 000 |
| 00817914024790 | K972901 | 000 |
| 00849593019705 | K972901 | 000 |