The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Torque Limiter.
Device ID | K952120 |
510k Number | K952120 |
Device Name: | TORQUE LIMITER |
Classification | Implant, Endosseous, Root-form |
Applicant | STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
Contact | Paul Gasser |
Correspondent | Paul Gasser STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-05 |
Decision Date | 1995-06-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TORQUE LIMITER 73206674 1175591 Dead/Cancelled |
Kesselman; David A. 1979-03-09 |