The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for Wall Bucky Holders Lt. & Rt. Hand, & Center Mount.
Device ID | K925934 |
510k Number | K925934 |
Device Name: | WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT |
Classification | Holder, Radiographic Cassette, Wall-mounted |
Applicant | CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
Contact | Oscar Khutoryansky |
Correspondent | Oscar Khutoryansky CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
Product Code | IXY |
CFR Regulation Number | 892.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-20 |
Decision Date | 1993-03-04 |