The following data is part of a premarket notification filed by Sentec Corp. with the FDA for Sentec Laser Guide Line, Model Sgl-05.
| Device ID | K862340 |
| 510k Number | K862340 |
| Device Name: | SENTEC LASER GUIDE LINE, MODEL SGL-05 |
| Classification | Collimator, Automatic, Radiographic |
| Applicant | SENTEC CORP. 460 NORTH WOODWARD Birmingham, MI 48011 |
| Contact | Sawatari, Phd |
| Correspondent | Sawatari, Phd SENTEC CORP. 460 NORTH WOODWARD Birmingham, MI 48011 |
| Product Code | IZW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-20 |
| Decision Date | 1986-07-11 |