The following data is part of a premarket notification filed by Js & R - R & D Co. with the FDA for Shiner Stress Directing Attachment.
Device ID | K863243 |
510k Number | K863243 |
Device Name: | SHINER STRESS DIRECTING ATTACHMENT |
Classification | Attachment, Precision, All |
Applicant | JS & R - R & D CO. DENTAL ATTACHMENT SYSTEMS 3415 LARK STREET San Diego, CA 92103 |
Contact | Jim Shiner |
Correspondent | Jim Shiner JS & R - R & D CO. DENTAL ATTACHMENT SYSTEMS 3415 LARK STREET San Diego, CA 92103 |
Product Code | EGG |
CFR Regulation Number | 872.3165 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-22 |
Decision Date | 1986-10-30 |