The following data is part of a premarket notification filed by Cgr Medical Corp. with the FDA for Prestilix 1690.
Device ID | K843926 |
510k Number | K843926 |
Device Name: | PRESTILIX 1690 |
Classification | Table, Radiographic, Tilting |
Applicant | CGR MEDICAL CORP. 10150 OLD COLUMBIA RD. Columbia, MD 21046 |
Contact | Dennis E Upright |
Correspondent | Dennis E Upright CGR MEDICAL CORP. 10150 OLD COLUMBIA RD. Columbia, MD 21046 |
Product Code | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-27 |
Decision Date | 1984-12-17 |