The following data is part of a premarket notification filed by Ama Network Inc with the FDA for Olive Plus.
Device ID | K161981 |
510k Number | K161981 |
Device Name: | Olive Plus |
Classification | Powered Laser Surgical Instrument |
Applicant | AMA NETWORK INC 3600 WILSHIRE BLVD #1016 Los Angeles, CA 90010 |
Contact | Yong Baik Kimm |
Correspondent | Young Chi BIO-MED USA INC. 27 NEW ENGLAND DRIVE Ramsey, NJ 07446 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-07-19 |
Decision Date | 2016-10-14 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OLIVE PLUS 77424690 not registered Dead/Abandoned |
ACH Food Companies, Inc. 2008-03-18 |