The following data is part of a premarket notification filed by Atomic Products Corp. with the FDA for Economy C-arm Table, Model # 056-005.
Device ID | K904187 |
510k Number | K904187 |
Device Name: | ECONOMY C-ARM TABLE, MODEL # 056-005 |
Classification | Table, Radiographic, Stationary Top |
Applicant | ATOMIC PRODUCTS CORP. P.O. DRAWER R Shirley, NY 11967 |
Contact | Clyde Schlein |
Correspondent | Clyde Schlein ATOMIC PRODUCTS CORP. P.O. DRAWER R Shirley, NY 11967 |
Product Code | IXQ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-12 |
Decision Date | 1990-11-29 |