The following data is part of a premarket notification filed by U.s. Imaging Tables, Inc. with the FDA for Vacs Table, 9650.
Device ID | K953556 |
510k Number | K953556 |
Device Name: | VACS TABLE, 9650 |
Classification | Table, Radiographic, Tilting |
Applicant | U.S. IMAGING TABLES, INC. 6 BAYVIEW AVE. Northport, NY 11768 |
Contact | Ronald Denezzo |
Correspondent | Ronald Denezzo U.S. IMAGING TABLES, INC. 6 BAYVIEW AVE. Northport, NY 11768 |
Product Code | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-17 |
Decision Date | 1995-09-26 |