The following data is part of a premarket notification filed by Trice Medical, Inc. with the FDA for Camera Enabled Probe.
Device ID | K141119 |
510k Number | K141119 |
Device Name: | CAMERA ENABLED PROBE |
Classification | Arthroscope |
Applicant | TRICE MEDICAL, INC. 1000 CONTINENTAL DRIVE, SUITE 240 King Of Prussia, PA 19406 |
Contact | Tiffini Diage |
Correspondent | Tiffini Diage TRICE MEDICAL, INC. 1000 CONTINENTAL DRIVE, SUITE 240 King Of Prussia, PA 19406 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-30 |
Decision Date | 2014-07-29 |
Summary: | summary |