The following data is part of a premarket notification filed by Hiossen, Inc. with the FDA for Is3.
Device ID | K180527 |
510k Number | K180527 |
Device Name: | IS3 |
Classification | Handpiece, Direct Drive, Ac-powered |
Applicant | Hiossen, Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
Contact | David Kim |
Correspondent | David Kim Hiossen, Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
Product Code | EKX |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-02-28 |
Decision Date | 2018-05-16 |
Summary: | summary |