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 |