The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Adac Xl-plan-pc.
Device ID | K920041 |
510k Number | K920041 |
Device Name: | ADAC XL-PLAN-PC |
Classification | Accelerator, Linear, Medical |
Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Contact | Paul Vicha |
Correspondent | Paul Vicha ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-06 |
Decision Date | 1992-03-30 |