The following data is part of a premarket notification filed by Sanko X-ray Manufacturing Co., Ltd. with the FDA for Sanko Intraoral Dental X-ray.
| Device ID | K972921 |
| 510k Number | K972921 |
| Device Name: | SANKO INTRAORAL DENTAL X-RAY |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | SANKO X-RAY MANUFACTURING CO., LTD. 904 KEMPSVILLE RD., SUITE 103 Virginia Beach, VA 23464 |
| Contact | Warren E Sachs |
| Correspondent | Warren E Sachs SANKO X-RAY MANUFACTURING CO., LTD. 904 KEMPSVILLE RD., SUITE 103 Virginia Beach, VA 23464 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-08 |
| Decision Date | 1998-01-06 |