The following data is part of a premarket notification filed by Umbel Corporation with the FDA for Zf 720.
Device ID | K132551 |
510k Number | K132551 |
Device Name: | ZF 720 |
Classification | Light, Surgical, Ceiling Mounted |
Applicant | UMBEL CORPORATION 2339 CANYON PARK DR. Diamond Bar, CA 91765 |
Contact | Hayden Wood |
Correspondent | Hayden Wood UMBEL CORPORATION 2339 CANYON PARK DR. Diamond Bar, CA 91765 |
Product Code | FSY |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-14 |
Decision Date | 2014-06-30 |
Summary: | summary |