The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Micromlc.
Device ID | K032790 |
510k Number | K032790 |
Device Name: | MICROMLC |
Classification | Block, Beam-shaping, Radiation Therapy |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 4040 NELSON AVE. Concord, CA 94520 |
Contact | Ken Nehmer |
Correspondent | Ken Nehmer SIEMENS MEDICAL SOLUTIONS USA, INC. 4040 NELSON AVE. Concord, CA 94520 |
Product Code | IXI |
CFR Regulation Number | 892.5710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-08 |
Decision Date | 2003-10-02 |
Summary: | summary |