The following data is part of a premarket notification filed by Pfizer Medical Systems, Inc. with the FDA for Radiation Therapy Treat. Plan. Sys..
Device ID | K780278 |
510k Number | K780278 |
Device Name: | RADIATION THERAPY TREAT. PLAN. SYS. |
Classification | System, Therapeutic, X-ray |
Applicant | PFIZER MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JAD |
CFR Regulation Number | 892.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-02-17 |
Decision Date | 1978-03-02 |