The following data is part of a premarket notification filed by Prowess, Inc. with the FDA for Panther Stereoseed.
Device ID | K143514 |
510k Number | K143514 |
Device Name: | Panther StereoSeed |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | PROWESS, INC. 1844 CLAYTON ROAD Concord, CA 94520 |
Contact | Rachel Scarano |
Correspondent | Rachel Scarano PROWESS, INC. 1844 CLAYTON ROAD Concord, CA 94520 |
Product Code | MUJ |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-11 |
Decision Date | 2015-12-11 |
Summary: | summary |