The following data is part of a premarket notification filed by Transamerican Technologies Intl. with the FDA for Accu-beam Tissue Drill & Aspiration/injection Needle.
| Device ID | K934398 |
| 510k Number | K934398 |
| Device Name: | ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TRANSAMERICAN TECHNOLOGIES INTL. 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Contact | Lowell Crow |
| Correspondent | Lowell Crow TRANSAMERICAN TECHNOLOGIES INTL. 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-08 |
| Decision Date | 1994-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B17798510 | K934398 | 000 |
| B17798500 | K934398 | 000 |