The following data is part of a premarket notification filed by Precision Dynamics Corporation with the FDA for Comfort Cover.
Device ID | K161920 |
510k Number | K161920 |
Device Name: | Comfort Cover |
Classification | System, X-ray, Mammographic |
Applicant | PRECISION DYNAMICS CORPORATION 27770 ENTERTAINMENT DRIVE, STE 200 Valencia, CA 91355 |
Contact | Swarna Mukund |
Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
Product Code | IZH |
CFR Regulation Number | 892.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2016-07-13 |
Decision Date | 2016-07-15 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COMFORT COVER 86591975 not registered Dead/Abandoned |
Precision Dynamics Corporation 2015-04-09 |
COMFORT COVER 85358763 not registered Dead/Abandoned |
PRECISION DYNAMICS CORPORATION 2011-06-28 |
COMFORT COVER 78724571 3295152 Live/Registered |
LPI, INC. 2005-09-30 |
COMFORT COVER 76615060 not registered Dead/Abandoned |
Nichols, June 2004-10-08 |
COMFORT COVER 76604518 not registered Dead/Abandoned |
ORTHO TECHNOLOGY, INC. 2004-07-28 |
COMFORT COVER 75637042 2319174 Dead/Cancelled |
VALLEY VETERINARY CLINIC LTD. 1999-02-10 |
COMFORT COVER 75265252 2371418 Dead/Cancelled |
Gain, Incorporated 1997-03-27 |
COMFORT COVER 73777685 not registered Dead/Abandoned |
COMFORT COVER INC. 1989-01-30 |