The following data is part of a premarket notification filed by Jindell Medical Instruments Co., Ltd. with the FDA for Jindell High Spped Air Turbine Handpiece, Models Sw, Sp, Su, Etu, Mu.
Device ID | K062740 |
510k Number | K062740 |
Device Name: | JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU |
Classification | Handpiece, Air-powered, Dental |
Applicant | JINDELL MEDICAL INSTRUMENTS CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
Contact | Ke-min Jen |
Correspondent | Ke-min Jen JINDELL MEDICAL INSTRUMENTS CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-13 |
Decision Date | 2006-11-02 |
Summary: | summary |