The following data is part of a premarket notification filed by Zhermack S.p.a. with the FDA for Elite Glass.
Device ID | K073005 |
510k Number | K073005 |
Device Name: | ELITE GLASS |
Classification | Material, Impression |
Applicant | ZHERMACK S.P.A. 19379 BLUE LAKE LOOP Bend, OR 97702 |
Contact | Gerald W Shipps |
Correspondent | Gerald W Shipps ZHERMACK S.P.A. 19379 BLUE LAKE LOOP Bend, OR 97702 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-24 |
Decision Date | 2007-12-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ELITE GLASS 88496692 not registered Live/Pending |
Elite Glass, LLC 2019-07-01 |