The following data is part of a premarket notification filed by Pfizer Medical Systems, Inc. with the FDA for Pfizer Pz-slm Rad. Therapy Trtmt. Simul..
Device ID | K803032 |
510k Number | K803032 |
Device Name: | PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL. |
Classification | System, Simulation, Radiation Therapy |
Applicant | PFIZER MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KPQ |
CFR Regulation Number | 892.5840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-12-01 |
Decision Date | 1981-01-22 |