The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Tri Auto Zx.
Device ID | K970339 |
510k Number | K970339 |
Device Name: | TRI AUTO ZX |
Classification | Handpiece, Direct Drive, Ac-powered |
Applicant | J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
Contact | Terry G Mahn |
Correspondent | Terry G Mahn J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
Product Code | EKX |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-01-29 |
Decision Date | 1997-06-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TRI AUTO ZX 79274481 not registered Live/Pending |
J. MORITA MFG. CORP. 2019-10-31 |