The following data is part of a premarket notification filed by Transamerican Technologies Intl. with the FDA for Accu-surg Bi-polar Electrodes, L-hook, Needle, Ball, Bipolar Cord.
| Device ID | K971677 |
| 510k Number | K971677 |
| Device Name: | ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | TRANSAMERICAN TECHNOLOGIES INTL. 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Contact | Allen R Howes |
| Correspondent | Allen R Howes TRANSAMERICAN TECHNOLOGIES INTL. 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-07 |
| Decision Date | 1997-08-20 |