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 |