The following data is part of a premarket notification filed by Dept. Of The Army with the FDA for Hand Held Dental X-ray Device.
Device ID | K934818 |
510k Number | K934818 |
Device Name: | HAND HELD DENTAL X-RAY DEVICE |
Classification | System, X-ray, Mobile |
Applicant | DEPT. OF THE ARMY 5109 LEESBURG PIKE Falls Church, VA 22041 |
Contact | Dale G Vander Hamm |
Correspondent | Dale G Vander Hamm DEPT. OF THE ARMY 5109 LEESBURG PIKE Falls Church, VA 22041 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-07 |
Decision Date | 1994-01-24 |