The following data is part of a premarket notification filed by Hofmann X-ray Of America, Inc. with the FDA for Super Speed Potter-bucky (eso5-110 & 220).
Device ID | K893690 |
510k Number | K893690 |
Device Name: | SUPER SPEED POTTER-BUCKY (ESO5-110 & 220) |
Classification | Table, Radiographic, Stationary Top |
Applicant | HOFMANN X-RAY OF AMERICA, INC. 16540 ASTON ST. Irvine, CA 92714 -4805 |
Contact | Robert Doubledee |
Correspondent | Robert Doubledee HOFMANN X-RAY OF AMERICA, INC. 16540 ASTON ST. Irvine, CA 92714 -4805 |
Product Code | IXQ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-16 |
Decision Date | 1989-07-20 |