The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Crc 15ultra.
Device ID | K052595 |
510k Number | K052595 |
Device Name: | CRC 15ULTRA |
Classification | System, Applicator, Radionuclide, Remote-controlled |
Applicant | CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
Contact | Mary Anne Dell |
Correspondent | Mary Anne Dell CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
Product Code | JAQ |
CFR Regulation Number | 892.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-21 |
Decision Date | 2005-11-08 |
Summary: | summary |