The following data is part of a premarket notification filed by American Biosurgical, Inc. with the FDA for American Biosurgical Electrosurgical Monopolar Cable/cord.
| Device ID | K971540 |
| 510k Number | K971540 |
| Device Name: | AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR 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 | 1997-04-28 |
| Decision Date | 1997-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852028007130 | K971540 | 000 |
| 00849593024990 | K971540 | 000 |
| 10849593024720 | K971540 | 000 |
| 10849593024744 | K971540 | 000 |
| 10849593024768 | K971540 | 000 |
| 10849593024782 | K971540 | 000 |
| 00849593019606 | K971540 | 000 |
| 10849593019795 | K971540 | 000 |
| 10849593019856 | K971540 | 000 |
| 10849593019733 | K971540 | 000 |
| 00849593019811 | K971540 | 000 |
| 00849593019873 | K971540 | 000 |
| 00852028007031 | K971540 | 000 |
| 00852028007079 | K971540 | 000 |
| 00852028007086 | K971540 | 000 |
| 00852028007093 | K971540 | 000 |
| 00852028007123 | K971540 | 000 |
| 00849593025058 | K971540 | 000 |