The following data is part of a premarket notification filed by Denar Corp. with the FDA for Steri-oss.
Device ID | K884845 |
510k Number | K884845 |
Device Name: | STERI-OSS |
Classification | Implant, Endosseous, Root-form |
Applicant | DENAR CORP. 901 E. CERRITOS AVE. Anaheim, CA 92805 |
Contact | Steve Hurson |
Correspondent | Steve Hurson DENAR CORP. 901 E. CERRITOS AVE. Anaheim, CA 92805 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-21 |
Decision Date | 1989-02-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() STERI-OSS 73571708 1410350 Dead/Cancelled |
DENAR CORPORATION 1985-12-05 |