The following data is part of a premarket notification filed by Manna Omni International Inc. with the FDA for Max Adjusting Instrument.
| Device ID | K082218 |
| 510k Number | K082218 |
| Device Name: | MAX ADJUSTING INSTRUMENT |
| Classification | Manipulator, Plunger-like Joint |
| Applicant | MANNA OMNI INTERNATIONAL INC. 340 E. COMMONWEALTH AVE. Fullerton, CA 92832 |
| Contact | Stephen Tsai |
| Correspondent | Stephen Tsai MANNA OMNI INTERNATIONAL INC. 340 E. COMMONWEALTH AVE. Fullerton, CA 92832 |
| Product Code | LXM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-06 |
| Decision Date | 2008-08-13 |
| Summary: | summary |