The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Shadow Trays.
Device ID | K991107 |
510k Number | K991107 |
Device Name: | SHADOW TRAYS |
Classification | Accelerator, Linear, Medical |
Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. 1470 OUTLOOK AVE. P.O. BOX 99 Bronx, NY 10465 |
Contact | Felix Mick |
Correspondent | Felix Mick MICK RADIO-NUCLEAR INSTRUMENTS, INC. 1470 OUTLOOK AVE. P.O. BOX 99 Bronx, NY 10465 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-01 |
Decision Date | 1999-06-29 |
Summary: | summary |