The following data is part of a premarket notification filed by Technicare Corp. with the FDA for Delta Plan Ii Radiation Therapy Plan.
Device ID | K820310 |
510k Number | K820310 |
Device Name: | DELTA PLAN II RADIATION THERAPY PLAN |
Classification | Accelerator, Linear, Medical |
Applicant | TECHNICARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-05 |
Decision Date | 1982-03-31 |