The following data is part of a premarket notification filed by Nucletron-oldelft Corp. with the FDA for Model Cole Tab-2 Table W/model Cole Sfd-2 Spotfilm.
Device ID | K926407 |
510k Number | K926407 |
Device Name: | MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM |
Classification | Table, Radiologic |
Applicant | NUCLETRON-OLDELFT CORP. BOX 786 Urbanna, VA 23175 |
Contact | David P Armstrong |
Correspondent | David P Armstrong NUCLETRON-OLDELFT CORP. BOX 786 Urbanna, VA 23175 |
Product Code | KXJ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-21 |
Decision Date | 1993-03-31 |