The following data is part of a premarket notification filed by Diacor, Inc. with the FDA for Integra Immobilization System.
Device ID | K050888 |
510k Number | K050888 |
Device Name: | INTEGRA IMMOBILIZATION SYSTEM |
Classification | Accelerator, Linear, Medical |
Applicant | DIACOR, INC. 3191 SOUTH 3300 EAST, SUITE 100-A Salt Lake City, UT 84109 |
Contact | Glenn N Waterman |
Correspondent | Glenn N Waterman DIACOR, INC. 3191 SOUTH 3300 EAST, SUITE 100-A Salt Lake City, UT 84109 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-04-07 |
Decision Date | 2005-05-23 |
Summary: | summary |