The following data is part of a premarket notification filed by Transamerican Technologies Intl. with the FDA for Accu-beam Laser Block 301513bg385/beam Splitters 301513bg39.
| Device ID | K963193 |
| 510k Number | K963193 |
| Device Name: | ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39 |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-15 |
| Decision Date | 1996-11-13 |